## Protocol Section
### Identification Module
**NCT ID:** NCT00972179

**Brief Title:** Safety Study of Tezepelumab (AMG 157) in Healthy Adults

**Official Title:** A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 157 in Healthy Subjects

#### Organization Study ID Info
**ID:** 20080390
#### Organization
**Class:** INDUSTRY
**Full Name:** Amgen
### Status Module
#### Completion Date
**Date:** 2011-01-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-09-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-09-08

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-01-09

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2022-05-23

**Type:** ACTUAL

**Results First Submit Date:** 2022-03-09

**Results First Submit QC Date:** 2022-03-09

#### Start Date
**Date:** 2009-09-15

**Type:** ACTUAL

**Status Verified Date:** 2022-09

#### Study First Post Date
**Date:** 2009-09-04
**Type:** ESTIMATED
**Study First Submit Date:** 2009-09-03
**Study First Submit QC Date:** 2009-09-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Amgen

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** The primary objective is to evaluate the safety, tolerability, and immunogenicity of multiple-dose administration of tezepelumab in healthy adults.

**Detailed Description:** This study will follow a randomized, multiple-dose, double-blind, placebo-controlled, sequential dose-escalation study design. The study will consist of five subcutaneous (SC) cohorts and one intravenous (IV) cohort. Each dose cohort is planned to enroll 8 participants, randomized such that 6 participants will receive tezepelumab and 2 will receive placebo (3:1 ratio).

### Conditions Module

**Conditions:**

- Healthy Volunteers

**Keywords:**

- healthy volunteers

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

**Intervention Model Description:** The cohorts will enroll sequentially: enrollment to the subsequent cohort (ie, next higher dose) will proceed only after the previous dose is determined to be safe and well tolerated by a blinded review of available safety data conducted on day 43 of the previous cohort. Within each dose cohort, participants will be randomized 3:1 to receive tezepelumab or placebo.

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 49

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Tezepelumab will be administered subcutaneously (SC) at doses from 35 mg once every 28 days (Q28D) (cohort 1) up to 210 mg once every 7 days (Q7D) (cohort 5) and an intravenous (IV) dose cohort of 700 mg Q28D (cohort 6).

**Intervention Names:**

- Drug: Tezepelumab

**Label:** Tezepelumab

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Two participants in each cohort (cohorts 1 to 6) will receive matching placebo administered subcutaneously (cohorts 1-5) or intravenously (cohort 6), matching the treatment regiment of tezepelumab.

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Placebo

**Description:** Administered by subcutaneous or intravenous injection.

**Name:** Placebo

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Tezepelumab

**Description:** Administered by subcutaneous or intravenous injection

**Name:** Tezepelumab

**Other Names:**

- AMG 157

- Tezspire

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Adverse events (AEs) include any untoward medical occurrence in a trial participant administered a study drug and does not necessarily have a causal relationship with this treatment. AEs include worsening of a pre-existing medical condition and laboratory value changes requiring therapy or adjustment in prior therapy.

AEs were assessed for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE and Grade 5 = death due to AE.

Relationship to study treatment was determined by the investigator.

A serious adverse event (SAE) is defined as an AE that met 1 or more of below criteria:

* was fatal;
* was life threatening;
* required in-patient hospitalization or prolongation of existing hospitalization;
* resulted in persistent or significant disability/incapacity;
* was a congenital anomaly/birth defect;
* other significant medical hazard.

**Measure:** Number of Participants With Treatment-emergent Adverse Events

**Time Frame:** From first dose of study drug up to day 169

**Description:** All study samples (tezepelumab and placebo) were tested using an electrochemiluminescence (ECL) based immunoassay to detect and confirm the presence of antibodies capable of binding to tezepelumab. Samples identified as positive in the immunoassay were tested in a receptor-binding ECL-based assay to detect neutralizing or inhibitory effects toward tezepelumab.

The number of participants with positive anti-tezepelumab binding antibodies / neutralizing antibodies at any time post-baseline with a negative or no result at baseline is reported.

**Measure:** Number of Participants Who Developed Anti-tezepelumab Antibodies After Initiation of Treatment

**Time Frame:** For Q28D groups: Days 28, 56, 85, 113, and 169; For Q14D and Q7D groups: Days 29, 57, 85, 113, 141, and 169

#### Secondary Outcomes

**Description:** The pharmacokinetic (PK) parameter Tmax was estimated based on the serum concentrations of tezepelumab using noncompartmental methods.

The concentration of tezepelumab in human serum was measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification of the assay was 10 ng/ml.

**Measure:** Time of Maximum Observed Concentration (Tmax) of Tezepelumab

**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose

**Description:** The PK parameter Cmax was estimated based on the serum concentrations of tezepelumab using noncompartmental methods. The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/ml.

**Measure:** Maximum Observed Concentration (Cmax) of Tezepelumab

**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose

**Description:** The PK parameter AUCtau was estimated based on the serum concentrations of tezepelumab using noncompartmental methods.

The dosing interval (tau) was 28 days, 14 days or 7 days depending on the treatment arm.

The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/ml.

**Measure:** Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) for Tezepelumab

**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose

**Description:** Accumulation ratio (AR) based on AUCtau was calculated as AUCtau after last dose / AUCtau after first dose, except for the Q7D cohort where AR was calculated as AUCtau after last dose / area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) after first dose.

**Measure:** Accumulation Ratio Based on AUCtau

**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose

**Description:** Accumulation ratio based on Cmax calculated as Cmax after last dose / Cmax after first dose

**Measure:** Accumulation Ratio Based on Cmax

**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subjects must sign an Institutional Review Board (IRB) approved informed consent form before any study-specific procedures;
* Healthy subject, aged between 18 and 45 years, inclusive;
* Female subject must be of non-reproductive potential (ie, postmenopausal by history - no menses for ≥ 1 year and by follicle-stimulating hormone (FSH) \[using local reference ranges\]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy);
* Male subjects with female partner of childbearing potential who agrees to inform their female partner of their participation in this clinical study and use highly effective methods of birth control during the study. (Highly effective methods of birth control may include abstinence, vasectomy, or a condom with spermicide in combination with either hormonal birth control, intra-uterine device, or barrier methods used by the woman);
* Male subject who agrees to use birth control for five months after last dose of study medication, male subject who agrees not to donate sperm during the study and for five months after last dose of study medication;
* Healthy subject with a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive at screening;
* Subject must have normal or clinically acceptable physical examination and electrocardiogram (ECG) results prior to Day 1 based on the opinion of the investigator;
* Subject must have normal or clinically acceptable clinical laboratory tests at screening as determined by Amgen and the investigator;
* Subject must have adequate renal function (defined as creatinine clearance \> 80 mL/min using the Cockcroft Gault equation).

Exclusion Criteria:

* Subject who has history or evidence of a clinically significant disorder, condition or disease (including but not limited to cardiopulmonary, oncologic, immunologic, autoimmune, collagen vascular, renal, metabolic, hematologic or psychiatric), that, in the opinion of the Investigator in consultation with the Amgen physician, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
* Subject who has evidence of any active or suspected bacterial, viral, fungal or parasitic infections within the past 30 days prior to randomization (eg, common cold, viral syndrome, flu-like symptoms). Subject who, in the opinion of the investigator, has a high risk of parasitic disease is also excluded;
* Subject who has known positive tuberculin skin test (if not treated with appropriate chemoprophylaxis) or recent (within six months from randomization) exposure to an individual with active tuberculosis;
* Subject who has history of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within five years before randomization of the study;
* Subject who has known type I/II diabetes;
* Subject who uses nonprescription drugs within 14 days prior to randomization and for the entire duration of the study. All herbal supplements, vitamins, and nutritional supplements taken within the last 30 days prior to dosing on Day 1 (and continued use, if appropriate), must be reviewed and approved by the PI and Amgen Medical Monitor;
* Subject who has used any systemic cytotoxic or systemic immunosuppressive medications (other than corticosteroids) within 6 months prior to randomization and for the entire duration of the study or has used any corticosteroid, topical cytotoxic or topical immunosuppressive medications within 30 days or five half-lives (whichever is longer) prior to randomization and for the entire duration of the study;
* Subject who has previously received any other therapeutic monoclonal antibody;
* Subject who has previously received any investigational drug (or is currently using an investigational device) within 30 days or five half-lives (whichever is longer) prior to randomization;
* Subject who has tested positive for drugs and/or alcohol use at screening or before randomization, subject who has consumed alcohol within 48 hours prior to any study visit including screening, and subject with alcohol intake of \> 2 drinks/day on average during the study (one drink being equivalent to 12 ounces of regular beer, 8 to 9 ounces of malt liquor, 5 ounces of wine or 1.5 ounces of 80 proof distilled spirits);
* Female subject who is pregnant or lactating; female subject who is of child-bearing potential;
* Subject who has donated blood (including blood products) or experienced loss of blood ≥ 500 mL within two months of study screening;
* Subject who is positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen, or hepatitis C antibodies;
* Subject who has regularly used nicotine or tobacco containing products (including but not limited to: snuff, chewing tobacco, cigars, cigarettes, pipes, or nicotine patches) during six months before randomization and during the study;
* Subject who has any other condition that might reduce the chance of obtaining data (eg, known poor compliance) required by the protocol or that might compromise the ability to give truly informed consent.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Amgen

**Name:** MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Parnes JR, Sullivan JT, Chen L, Dias C. Pharmacokinetics, Safety, and Tolerability of Tezepelumab (AMG 157) in Healthy and Atopic Dermatitis Adult Subjects. Clin Pharmacol Ther. 2019 Aug;106(2):441-449. doi: 10.1002/cpt.1401. Epub 2019 Mar 23.

**PMID:** 30779339

#### See Also Links

**Label:** AmgenTrials clinical trials website

**URL:** http://www.amgentrials.com

## Derived Section

### Misc Info Module

#### Removed Countries

- Country: United States

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Tezepelumab 35 mg Q28D

**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.

**ID:** EG000

**Other Num Affected:** 4

**Other Num at Risk:** 6

**Serious Number Affected:** 1

**Serious Number At Risk:** 6

**Title:** Tezepelumab 35 mg Q28D

**Group ID:** EG001

**Title:** Tezepelumab 105 mg Q28D

**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.

**ID:** EG001

**Other Num Affected:** 4

**Other Num at Risk:** 6

**Serious Number At Risk:** 6

**Title:** Tezepelumab 105 mg Q28D

**Group ID:** EG002

**Title:** Tezepelumab 210 mg Q28D

**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.

**ID:** EG002

**Other Num Affected:** 2

**Other Num at Risk:** 6

**Serious Number At Risk:** 6

**Title:** Tezepelumab 210 mg Q28D

**Group ID:** EG003

**Title:** Tezepelumab 210 mg Q14D

**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.

**ID:** EG003

**Other Num Affected:** 6

**Other Num at Risk:** 6

**Serious Number At Risk:** 6

**Title:** Tezepelumab 210 mg Q14D

**Group ID:** EG004

**Title:** Tezepelumab 210 mg Q7D

**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.

**ID:** EG004

**Other Num Affected:** 5

**Other Num at Risk:** 7

**Serious Number At Risk:** 7

**Title:** Tezepelumab 210 mg Q7D

**Group ID:** EG005

**Title:** Tezepelumab 700 mg Q28D IV

**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.

**ID:** EG005

**Other Num Affected:** 3

**Other Num at Risk:** 6

**Serious Number At Risk:** 6

**Title:** Tezepelumab 700 mg Q28D IV

**Group ID:** EG006

**Title:** Tezepelumab Total

**Description:** All participants who received tezepelumab.

**ID:** EG006

**Other Num Affected:** 24

**Other Num at Risk:** 37

**Serious Number Affected:** 1

**Serious Number At Risk:** 37

**Title:** Tezepelumab Total

**Group ID:** EG007

**Title:** Placebo

**Description:** Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.

**ID:** EG007

**Other Num Affected:** 10

**Other Num at Risk:** 12

**Serious Number At Risk:** 12

**Title:** Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** Eye irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Abdominal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Flatulence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Application site dermatitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Fatigue

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Influenza like illness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Injection site haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Injection site haemorrhage

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Injection site irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Injection site pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Injection site pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Injection site swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Injection site urticaria

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Pyrexia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Hypersensitivity

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Immune system disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Bronchitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

**Term:** Hepatitis C

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

**Term:** Influenza

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

**Term:** Upper respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

**Term:** Viral infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

**Term:** Burns first degree

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 14.1

**Term:** Corneal abrasion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 14.1

**Term:** Eye injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 14.1

**Term:** Joint injury

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 14.1

**Term:** Skin laceration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 14.1

**Term:** Sunburn

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA 14.1

**Term:** Aspartate aminotransferase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

**Term:** Blood creatine phosphokinase increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

**Term:** Body temperature increased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 14.1

**Term:** Dehydration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Hyponatraemia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Increased appetite

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Polydipsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Muscle spasms

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Muscular weakness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Musculoskeletal stiffness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Myalgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Dizziness

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Syncope

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Insomnia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Cough

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Oropharyngeal pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Sinus congestion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Dermatitis contact

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Ecchymosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Pruritus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 14.1

**Term:** Haematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 14.1

#### Serious Events

**Term:** Hepatitis C

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA 14.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 6

**Group ID:** EG001

**Num At Risk:** 6

**Group ID:** EG002

**Num At Risk:** 6

**Group ID:** EG003

**Num At Risk:** 6

**Group ID:** EG004

**Num At Risk:** 7

**Group ID:** EG005

**Num At Risk:** 6

**Group ID:** EG006

**Num Affected:** 1

**Num At Risk:** 37

**Group ID:** EG007

**Num At Risk:** 12

**Time Frame:** From first dose of study drug up to day 169

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 6

**Group ID:** BG001

**Value:** 6

**Group ID:** BG002

**Value:** 6

**Group ID:** BG003

**Value:** 6

**Group ID:** BG004

**Value:** 7

**Group ID:** BG005

**Value:** 6

**Group ID:** BG006

**Value:** 12

**Group ID:** BG007

**Value:** 49

**Units:** Participants

### Group

**ID:** BG000

**Title:** Tezepelumab 35 mg Q28D

**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.

### Group

**ID:** BG001

**Title:** Tezepelumab 105 mg Q28D

**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.

### Group

**ID:** BG002

**Title:** Tezepelumab 210 mg Q28D

**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.

### Group

**ID:** BG003

**Title:** Tezepelumab 210 mg Q14D

**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.

### Group

**ID:** BG004

**Title:** Tezepelumab 210 mg Q7D

**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.

### Group

**ID:** BG005

**Title:** Tezepelumab 700 mg Q28D IV

**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.

### Group

**ID:** BG006

**Title:** Placebo

**Description:** Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.

### Group

**ID:** BG007

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.3

**Value:** 29.8

#### Measurement

**Group ID:** BG001

**Spread:** 5.8

**Value:** 34.8

#### Measurement

**Group ID:** BG002

**Spread:** 5.3

**Value:** 32.3

#### Measurement

**Group ID:** BG003

**Spread:** 5.6

**Value:** 31.5

#### Measurement

**Group ID:** BG004

**Spread:** 7.7

**Value:** 36.1

#### Measurement

**Group ID:** BG005

**Spread:** 4.1

**Value:** 27.7

#### Measurement

**Group ID:** BG006

**Spread:** 5.2

**Value:** 34.1

#### Measurement

**Group ID:** BG007

**Spread:** 6.4

**Value:** 32.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 4

#### Measurement

**Group ID:** BG004

**Value:** 1

#### Measurement

**Group ID:** BG005

**Value:** 0

#### Measurement

**Group ID:** BG006

**Value:** 2

#### Measurement

**Group ID:** BG007

**Value:** 7

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 6

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 2

#### Measurement

**Group ID:** BG004

**Value:** 6

#### Measurement

**Group ID:** BG005

**Value:** 6

#### Measurement

**Group ID:** BG006

**Value:** 10

#### Measurement

**Group ID:** BG007

**Value:** 42

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 2

#### Measurement

**Group ID:** BG003

**Value:** 1

#### Measurement

**Group ID:** BG004

**Value:** 4

#### Measurement

**Group ID:** BG005

**Value:** 3

#### Measurement

**Group ID:** BG006

**Value:** 4

#### Measurement

**Group ID:** BG007

**Value:** 17

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

#### Measurement

**Group ID:** BG003

**Value:** 0

#### Measurement

**Group ID:** BG004

**Value:** 0

#### Measurement

**Group ID:** BG005

**Value:** 2

#### Measurement

**Group ID:** BG006

**Value:** 1

#### Measurement

**Group ID:** BG007

**Value:** 3

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 5

#### Measurement

**Group ID:** BG004

**Value:** 3

#### Measurement

**Group ID:** BG005

**Value:** 1

#### Measurement

**Group ID:** BG006

**Value:** 7

#### Measurement

**Group ID:** BG007

**Value:** 29

**Category Title:** Hispanic or Latino

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** year
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** Participants
**Population Description:** Participants who received at least 1 dose of study drug (Safety population).
## Results Section - More Information Module
### Certain Agreement
**Other Details:** The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** medinfo@amgen.com
**Organization:** Amgen Inc.
**Phone:** 866-572-6436
**Title:** Study Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 69.7
- **Spread:** 
- **Upper Limit:** 167
- **Value:** 160
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 70.4
- **Spread:** 
- **Upper Limit:** 167
- **Value:** 71.5
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 68.7
- **Spread:** 
- **Upper Limit:** 166
- **Value:** 118
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 69.9
- **Spread:** 
- **Upper Limit:** 168
- **Value:** 70.7
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 66.9
- **Spread:** 
- **Upper Limit:** 165
- **Value:** 164
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 1.13
- **Spread:** 
- **Upper Limit:** 4.17
- **Value:** 4.00
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 6
- **Group ID:** OG003
- **Value:** 6
- **Group ID:** OG004
- **Value:** 7
- **Group ID:** OG005
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 68.6
- **Spread:** 
- **Upper Limit:** 176
- **Value:** 166
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 70.7
- **Spread:** 
- **Upper Limit:** 167
- **Value:** 71.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 69.3
- **Spread:** 
- **Upper Limit:** 168
- **Value:** 167
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 65.1
- **Spread:** 
- **Upper Limit:** 162
- **Value:** 66.5
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 65.9
- **Spread:** 
- **Upper Limit:** 164
- **Value:** 74.4
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 1.17
- **Spread:** 
- **Upper Limit:** 4.03
- **Value:** 3.97
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 3
- **Group ID:** OG002
- **Value:** 5
- **Group ID:** OG003
- **Value:** 6
- **Group ID:** OG004
- **Value:** 5
- **Group ID:** OG005
- **Value:** 5
**Units:** Participants
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG006
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.16
- **Upper Limit:** 
- **Value:** 3.70
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.13
- **Upper Limit:** 
- **Value:** 10.7
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 9.50
- **Upper Limit:** 
- **Value:** 23.6
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 5.40
- **Upper Limit:** 
- **Value:** 23.8
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 4.58
- **Upper Limit:** 
- **Value:** 18.0
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 48.2
- **Upper Limit:** 
- **Value:** 294
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 6
- **Group ID:** OG002
- **Value:** 6
- **Group ID:** OG003
- **Value:** 6
- **Group ID:** OG004
- **Value:** 7
- **Group ID:** OG005
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.02
- **Upper Limit:** 
- **Value:** 6.29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.02
- **Upper Limit:** 
- **Value:** 16.6
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 17.5
- **Upper Limit:** 
- **Value:** 37.4
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 13.5
- **Upper Limit:** 
- **Value:** 63.8
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 45.6
- **Upper Limit:** 
- **Value:** 117
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 74.9
- **Upper Limit:** 
- **Value:** 370
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 3
- **Group ID:** OG002
- **Value:** 5
- **Group ID:** OG003
- **Value:** 6
- **Group ID:** OG004
- **Value:** 5
- **Group ID:** OG005
- **Value:** 5
**Units:** Participants
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 23.4
- **Upper Limit:** 
- **Value:** 78.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 50.5
- **Upper Limit:** 
- **Value:** 237
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 171
- **Upper Limit:** 
- **Value:** 481
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 49.2
- **Upper Limit:** 
- **Value:** 263
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 34.9
- **Upper Limit:** 
- **Value:** 84.3
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 395
- **Upper Limit:** 
- **Value:** 2980
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 6
- **Group ID:** OG001
- **Value:** 5
- **Group ID:** OG002
- **Value:** 6
- **Group ID:** OG003
- **Value:** 6
- **Group ID:** OG004
- **Value:** 7
- **Group ID:** OG005
- **Value:** 6
**Units:** Participants
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 35.9
- **Upper Limit:** 
- **Value:** 136
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 28.8
- **Upper Limit:** 
- **Value:** 333
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 338
- **Upper Limit:** 
- **Value:** 799
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 180
- **Upper Limit:** 
- **Value:** 787
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 224
- **Upper Limit:** 
- **Value:** 732
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 1270
- **Upper Limit:** 
- **Value:** 4050
**Title:** 
**Denomination:**
- **Group ID:** OG000
- **Value:** 5
- **Group ID:** OG001
- **Value:** 3
- **Group ID:** OG002
- **Value:** 5
- **Group ID:** OG003
- **Value:** 6
- **Group ID:** OG004
- **Value:** 5
- **Group ID:** OG005
- **Value:** 5
**Units:** Participants
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.262
- **Upper Limit:** 
- **Value:** 1.82
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0883
- **Upper Limit:** 
- **Value:** 1.64
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.242
- **Upper Limit:** 
- **Value:** 1.59
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.892
- **Upper Limit:** 
- **Value:** 2.89
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 1.93
- **Upper Limit:** 
- **Value:** 8.23
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 0.314
- **Upper Limit:** 
- **Value:** 1.34
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.392
- **Upper Limit:** 
- **Value:** 1.79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.0901
- **Upper Limit:** 
- **Value:** 1.66
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.288
- **Upper Limit:** 
- **Value:** 1.59
- **Comment:** 
- **Group ID:** OG003
- **Lower Limit:** 
- **Spread:** 0.965
- **Upper Limit:** 
- **Value:** 2.84
- **Comment:** 
- **Group ID:** OG004
- **Lower Limit:** 
- **Spread:** 1.69
- **Upper Limit:** 
- **Value:** 6.74
- **Comment:** 
- **Group ID:** OG005
- **Lower Limit:** 
- **Spread:** 0.176
- **Upper Limit:** 
- **Value:** 1.30
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Adverse events (AEs) include any untoward medical occurrence in a trial participant administered a study drug and does not necessarily have a causal relationship with this treatment. AEs include worsening of a pre-existing medical condition and laboratory value changes requiring therapy or adjustment in prior therapy.

AEs were assessed for severity according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 3, where Grade 1 = Mild AE, Grade 2 = Moderate AE, Grade 3 = severe AE, Grade 4 = life-threatening AE and Grade 5 = death due to AE.

Relationship to study treatment was determined by the investigator.

A serious adverse event (SAE) is defined as an AE that met 1 or more of below criteria:

* was fatal;
* was life threatening;
* required in-patient hospitalization or prolongation of existing hospitalization;
* resulted in persistent or significant disability/incapacity;
* was a congenital anomaly/birth defect;
* other significant medical hazard.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** All participants who received at least 1 dose of study drug
**Reporting Status:** POSTED
**Time Frame:** From first dose of study drug up to day 169
**Title:** Number of Participants With Treatment-emergent Adverse Events
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
**ID:** OG000
**Title:** Tezepelumab 35 mg Q28D
##### Group
**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
**ID:** OG001
**Title:** Tezepelumab 105 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
**ID:** OG002
**Title:** Tezepelumab 210 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
**ID:** OG003
**Title:** Tezepelumab 210 mg Q14D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
**ID:** OG004
**Title:** Tezepelumab 210 mg Q7D
##### Group
**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
**ID:** OG005
**Title:** Tezepelumab 700 mg Q28D IV
##### Group
**Description:** Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
**ID:** OG006
**Title:** Placebo
#### Outcome Measure 2
**Description:** The pharmacokinetic (PK) parameter Tmax was estimated based on the serum concentrations of tezepelumab using noncompartmental methods.

The concentration of tezepelumab in human serum was measured using a validated enzyme-linked immunosorbent assay (ELISA). The lower limit of quantification of the assay was 10 ng/ml.
**Dispersion Type:** Full Range
**Parameter Type:** MEDIAN
**Population Description:** Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
**Reporting Status:** POSTED
**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose
**Title:** Time of Maximum Observed Concentration (Tmax) of Tezepelumab
**Type:** SECONDARY
**Unit of Measure:** hours
##### Group
**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
**ID:** OG000
**Title:** Tezepelumab 35 mg Q28D
##### Group
**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG001
**Title:** Tezepelumab 105 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG002
**Title:** Tezepelumab 210 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
**ID:** OG003
**Title:** Tezepelumab 210 mg Q14D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
**ID:** OG004
**Title:** Tezepelumab 210 mg Q7D
##### Group
**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
**ID:** OG005
**Title:** Tezepelumab 700 mg Q28D IV
#### Outcome Measure 3
**Description:** All study samples (tezepelumab and placebo) were tested using an electrochemiluminescence (ECL) based immunoassay to detect and confirm the presence of antibodies capable of binding to tezepelumab. Samples identified as positive in the immunoassay were tested in a receptor-binding ECL-based assay to detect neutralizing or inhibitory effects toward tezepelumab.

The number of participants with positive anti-tezepelumab binding antibodies / neutralizing antibodies at any time post-baseline with a negative or no result at baseline is reported.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** All participants who received at least 1 dose of study drug
**Reporting Status:** POSTED
**Time Frame:** For Q28D groups: Days 28, 56, 85, 113, and 169; For Q14D and Q7D groups: Days 29, 57, 85, 113, 141, and 169
**Title:** Number of Participants Who Developed Anti-tezepelumab Antibodies After Initiation of Treatment
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
**ID:** OG000
**Title:** Tezepelumab 35 mg Q28D
##### Group
**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG001
**Title:** Tezepelumab 105 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG002
**Title:** Tezepelumab 210 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
**ID:** OG003
**Title:** Tezepelumab 210 mg Q14D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
**ID:** OG004
**Title:** Tezepelumab 210 mg Q7D
##### Group
**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
**ID:** OG005
**Title:** Tezepelumab 700 mg Q28D IV
##### Group
**Description:** Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
**ID:** OG006
**Title:** Placebo
#### Outcome Measure 4
**Description:** The PK parameter Cmax was estimated based on the serum concentrations of tezepelumab using noncompartmental methods. The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/ml.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
**Reporting Status:** POSTED
**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose
**Title:** Maximum Observed Concentration (Cmax) of Tezepelumab
**Type:** SECONDARY
**Unit of Measure:** µg/mL
##### Group
**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
**ID:** OG000
**Title:** Tezepelumab 35 mg Q28D
##### Group
**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG001
**Title:** Tezepelumab 105 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG002
**Title:** Tezepelumab 210 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
**ID:** OG003
**Title:** Tezepelumab 210 mg Q14D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
**ID:** OG004
**Title:** Tezepelumab 210 mg Q7D
##### Group
**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
**ID:** OG005
**Title:** Tezepelumab 700 mg Q28D IV
#### Outcome Measure 5
**Description:** The PK parameter AUCtau was estimated based on the serum concentrations of tezepelumab using noncompartmental methods.

The dosing interval (tau) was 28 days, 14 days or 7 days depending on the treatment arm.

The concentration of tezepelumab in human serum was measured using a validated ELISA. The lower limit of quantification of the assay was 10 ng/ml.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
**Reporting Status:** POSTED
**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose
**Title:** Area Under the Concentration-time Curve Over the Dosing Interval (AUCtau) for Tezepelumab
**Type:** SECONDARY
**Unit of Measure:** days*µg/mL
##### Group
**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
**ID:** OG000
**Title:** Tezepelumab 35 mg Q28D
##### Group
**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG001
**Title:** Tezepelumab 105 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG002
**Title:** Tezepelumab 210 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
**ID:** OG003
**Title:** Tezepelumab 210 mg Q14D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
**ID:** OG004
**Title:** Tezepelumab 210 mg Q7D
##### Group
**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
**ID:** OG005
**Title:** Tezepelumab 700 mg Q28D IV
#### Outcome Measure 6
**Description:** Accumulation ratio (AR) based on AUCtau was calculated as AUCtau after last dose / AUCtau after first dose, except for the Q7D cohort where AR was calculated as AUCtau after last dose / area under the concentration-time curve from time 0 to time of last measurable concentration (AUC0-t) after first dose.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
**Reporting Status:** POSTED
**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose
**Title:** Accumulation Ratio Based on AUCtau
**Type:** SECONDARY
**Unit of Measure:** ratio
##### Group
**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
**ID:** OG000
**Title:** Tezepelumab 35 mg Q28D
##### Group
**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG001
**Title:** Tezepelumab 105 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG002
**Title:** Tezepelumab 210 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
**ID:** OG003
**Title:** Tezepelumab 210 mg Q14D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
**ID:** OG004
**Title:** Tezepelumab 210 mg Q7D
##### Group
**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
**ID:** OG005
**Title:** Tezepelumab 700 mg Q28D IV
#### Outcome Measure 7
**Description:** Accumulation ratio based on Cmax calculated as Cmax after last dose / Cmax after first dose
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Participants who received tezepelumab and had a sufficient number of serum concentration measurements for computing the PK parameter after first dose and after last dose.
**Reporting Status:** POSTED
**Time Frame:** First dose: Day 1 predose, end of infusion (EOI; IV cohort only), 4 hours, 3, 7, 14 (Q14D & Q28D only) and 28 days (Q28D only) postdose. Last Dose: Day 57 (Q28D), Day 71 (Q14D) and Day 78 (Q7D) predose, EOI (IV cohort), 4 hours, 3, 7, 14, 28 days postdose
**Title:** Accumulation Ratio Based on Cmax
**Type:** SECONDARY
**Unit of Measure:** ratio
##### Group
**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for three doses.
**ID:** OG000
**Title:** Tezepelumab 35 mg Q28D
##### Group
**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG001
**Title:** Tezepelumab 105 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for three doses.
**ID:** OG002
**Title:** Tezepelumab 210 mg Q28D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
**ID:** OG003
**Title:** Tezepelumab 210 mg Q14D
##### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
**ID:** OG004
**Title:** Tezepelumab 210 mg Q7D
##### Group
**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
**ID:** OG005
**Title:** Tezepelumab 700 mg Q28D IV
### Participant Flow Module
#### Group
**Description:** Participants received 35 mg tezepelumab by subcutaneous injection once every 28 days (Q28D) for 3 doses.
**ID:** FG000
**Title:** Tezepelumab 35 mg Q28D
#### Group
**Description:** Participants received 105 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
**ID:** FG001
**Title:** Tezepelumab 105 mg Q28D
#### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 28 days for 3 doses.
**ID:** FG002
**Title:** Tezepelumab 210 mg Q28D
#### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 14 days (Q14D) for 6 doses.
**ID:** FG003
**Title:** Tezepelumab 210 mg Q14D
#### Group
**Description:** Participants received 210 mg tezepelumab by subcutaneous injection once every 7 days (Q7D) for 12 doses.
**ID:** FG004
**Title:** Tezepelumab 210 mg Q7D
#### Group
**Description:** Participants received 700 mg tezepelumab by intravenous injection once every 28 days for 3 doses.
**ID:** FG005
**Title:** Tezepelumab 700 mg Q28D IV
#### Group
**Description:** Participants received matching placebo administered subcutaneously (Cohorts 1-5) or intravenously (Cohort 6), matching the treatment regimen of tezepelumab.
**ID:** FG006
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Noncompliance
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 1
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 2
##### Withdraw
**Type:** Administrative Decision
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 1
###### Reason
**Group ID:** FG005
**Number of Subjects:** 0
###### Reason
**Group ID:** FG006
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 1
###### Reason
**Group ID:** FG003
**Number of Subjects:** 0
###### Reason
**Group ID:** FG004
**Number of Subjects:** 0
###### Reason
**Group ID:** FG005
**Number of Subjects:** 3
###### Reason
**Group ID:** FG006
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 6
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 12
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 8
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG003
**Number of Subjects:** 1
###### Achievement
**Group ID:** FG004
**Number of Subjects:** 2
###### Achievement
**Group ID:** FG005
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG006
**Number of Subjects:** 4
**Pre-Assignment Details:** Participants were enrolled into 1 of 6 cohorts. In the first 5 cohorts escalating subcutaneous doses of tezepelumab were compared with placebo and in cohort 6 a regimen of intravenous tezepelumab was compared with placebo. Within each cohort, healthy participants were randomized at a 6:2 ratio to receive either tezepelumab or placebo.
**Recruitment Details:** This study was conducted at a single center in the United States.
**Has Results:** True