## Protocol Section
### Identification Module
**NCT ID:** NCT02348879

**Brief Title:** A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of AMG 403 in Healthy Subject

**Official Title:** A Placebo Controlled, Randomized, Double-blind, Sequential, Rising, Single Dose Study to Examine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous and Subcutaneous AMG 403 in Healthy Young and Older Adult Subjects

#### Organization Study ID Info
**ID:** 20040195
#### Organization
**Class:** INDUSTRY
**Full Name:** Amgen
### Status Module
#### Completion Date
**Date:** 2006-03

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-01-30

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-01-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2006-01

**Type:** ACTUAL

#### Start Date
**Date:** 2005-01

**Status Verified Date:** 2015-01

#### Study First Post Date
**Date:** 2015-01-28
**Type:** ESTIMATED
**Study First Submit Date:** 2014-12-23
**Study First Submit QC Date:** 2015-01-27
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Amgen

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study is to evaluate the safety of AMG 403 in healthy adult subjects. The study consists of a 21 day screening period followed by administration of the investigational product and up to 154 day evaluation period.

### Conditions Module

**Conditions:**

- Chronic Pain

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 51

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** AMG 403 administered as subcutaneous and intravenous doses

**Intervention Names:**

- Drug: AMG 403

**Label:** AMG 403

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No active drug

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- AMG 403

**Description:** AMG 403 is for treatment of subjects with chronic pain

**Name:** AMG 403

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** contains no active drug

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of treatment emergent adverse events

**Time Frame:** up to 112 days

**Description:** Vital signs to be assessed included temperature, respiratory rate, pulse rate and rhythm (regular/irregular), and blood pressure. Generally, abnormal vital signs were only reported as adverse events if they required treatment or were associated with an adverse event.

**Measure:** Incidence of abnormal clinically significant vital signs

**Time Frame:** up to 112 days

**Description:** Laboratory abnormalities were defined by laboratory normal ranges and were not reported as adverse events unless symptomatic or associated with an adverse event.

**Measure:** Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results

**Time Frame:** up to 112 days

**Description:** ECG abnormalities were reported as adverse events if they represented a change from baseline or if associated with symptoms or an adverse event.

**Measure:** Incidence of abnormal clinically significant ECG results

**Time Frame:** up to 112 days

#### Secondary Outcomes

**Measure:** Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax

**Time Frame:** up to 112 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy men and women of non-child bearing potential,
* Between the ages of 18 and 55 inclusive,
* Body mass index from 18 to 33 kg/m2,
* Skin type compatible with the study assessments, and without significant skin allergies, pigmentary disorders, tattoos, or any active dermatologic conditions that might interfere with the study conduct.

Exclusion Criteria:

* Prior or current history of peripheral neuropathy, paraesthesias, dysesthesias, herpes zoster, post-herpetic neuralgia,
* Evidence of any current illness such as a common cold, viral syndrome, or flu-like symptoms, any disturbance of the autonomic nervous system,
* History of Raynaud's phenomenon; Know allergy or intolerance to capsaicin or hot peppers.

**Healthy Volunteers:** True

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Amgen

**Name:** MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Gow JM, Tsuji WH, Williams GJ, Mytych D, Sciberras D, Searle SL, Mant T, Gibbs JP. Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects. Arthritis Res Ther. 2015 Oct 8;17:282. doi: 10.1186/s13075-015-0797-9.

**PMID:** 26449617

#### See Also Links

**Label:** AmgenTrials clinical trials website

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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M29442

- Name: Chronic Pain

- Relevance: HIGH

- As Found: Chronic Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059350

- Term: Chronic Pain

### Misc Info Module

- Version Holder: 2024-05-24
