## Protocol Section
### Identification Module
**NCT ID:** NCT06091579

**Brief Title:** A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder (TPIP) in Healthy Participants

**Official Title:** A Phase 1, Randomized, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, And Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Healthy Volunteers

#### Organization Study ID Info
**ID:** INS1009-102
#### Organization
**Class:** INDUSTRY
**Full Name:** Insmed Incorporated
### Status Module
#### Completion Date
**Date:** 2021-01-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-10-19

**Type:** ACTUAL

**Last Update Submit Date:** 2023-10-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-01-12

**Type:** ACTUAL

#### Start Date
**Date:** 2020-09-17

**Type:** ACTUAL

**Status Verified Date:** 2023-10

#### Study First Post Date
**Date:** 2023-10-19
**Type:** ACTUAL
**Study First Submit Date:** 2023-10-16
**Study First Submit QC Date:** 2023-10-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Insmed Incorporated

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary purpose of this study is to evaluate the safety and tolerability of single and multiple doses of treprostinil palmitil inhalation powder in healthy participants.

### Conditions Module

**Conditions:**

- Healthy Volunteers

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 42

**Type:** ACTUAL

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants in the single ascending dose (SAD) Cohort 1 received a single dose of TPIP at Dose A, Dose B, or Dose C by oral inhalation on Day 1.

**Intervention Names:**

- Drug: Treprostinil Palmitil Inhalation Powder

**Label:** Part A (SAD Cohort 1): TPIP

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Participants in SAD Cohort 2 received a single dose of TPIP at Dose D or matching placebo by oral inhalation on Day 1.

**Intervention Names:**

- Drug: Treprostinil Palmitil Inhalation Powder

- Drug: Placebo

**Label:** Part A (SAD Cohort 2): TPIP or Placebo

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Participants in SAD Cohort 3 received a single dose of TPIP at Dose E or matching placebo by oral inhalation on Day 1.

**Intervention Names:**

- Drug: Treprostinil Palmitil Inhalation Powder

- Drug: Placebo

**Label:** Part A (SAD Cohort 3): TPIP or Placebo

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Participants in the multiple ascending dose (MAD) Cohort 1 received TPIP at Dose B, Dose C or matching placebo, once daily (QD) by oral inhalation on Days 1 through 7.

**Intervention Names:**

- Drug: Treprostinil Palmitil Inhalation Powder

- Drug: Placebo

**Label:** Part B (MAD Cohort 1): TPIP or Placebo

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** Participants in MAD Cohort 2 received TPIP up to Dose D or matching placebo, QD by oral inhalation on Days 1 through 7.

**Intervention Names:**

- Drug: Treprostinil Palmitil Inhalation Powder

- Drug: Placebo

**Label:** Part B (MAD Cohort 2): TPIP or Placebo

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Part A (SAD Cohort 1): TPIP

- Part A (SAD Cohort 2): TPIP or Placebo

- Part A (SAD Cohort 3): TPIP or Placebo

- Part B (MAD Cohort 1): TPIP or Placebo

- Part B (MAD Cohort 2): TPIP or Placebo

**Description:** Oral inhalation using a Plastiape capsule-based dry powder inhaler.

**Name:** Treprostinil Palmitil Inhalation Powder

**Other Names:**

- INS1009

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Part A (SAD Cohort 2): TPIP or Placebo

- Part A (SAD Cohort 3): TPIP or Placebo

- Part B (MAD Cohort 1): TPIP or Placebo

- Part B (MAD Cohort 2): TPIP or Placebo

**Description:** Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Safety and tolerability of single and multiple doses of treprostinil inhalation powder will be determined in healthy participants.

**Measure:** Parts A and B: Number of Participants who Experienced an Adverse Event (AE)

**Time Frame:** Up to Day 31 in Part A and Day 37 in Part B

#### Secondary Outcomes

**Description:** Pharmacokinetics of treprostinil following a single and multiple doses will be assessed in healthy participants.

**Measure:** Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil

**Time Frame:** Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10

**Description:** Pharmacokinetics of treprostinil palmitil following a single and multiple doses will be assessed in healthy participants.

**Measure:** Parts A and B: Area Under the Plasma Concentration Versus Time Curve (AUC) of Treprostinil Palmitil

**Time Frame:** Part A: Predose and at multiple time points postdose up to Day 4; Part B: Predose and at multiple time points postdose up to Day 10

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* The participant is considered by the investigator to be in good general health as determined by medical history, physical examination findings, vital sign measurements, 12-lead electrocardiogram (ECG) results, and clinical laboratory test results within normal limits or considered not clinically significant by the investigator, at screening.

Exclusion Criteria:

* The participant has an allergy, documented hypersensitivity, or contraindication to the ingredients or to any of the excipients of treprostinil palmitil inhalation powder or treprostinil.
* The participant has used any prescription (excluding hormonal birth control) or over-the-counter medications, including herbal or nutritional supplements, within 14 days before the first dose of study drug and throughout the study.
* The participant has a history of anaphylaxis, previously documented hypersensitivity reaction to any drug.
* The participant has had a surgical procedure that required general anesthesia (or equivalent) within 90 days prior to screening.
* The participant has a body mass index \<19.0 or \>32.0 kilograms per square meter (kg/m\^2) at screening.
* The participant has a history of syncope not due to dehydration or vasovagal syncope (eg, congenital cardiac arrhythmias such as Wolff-Parkinson-White syndrome, nodal tachycardia, ventricular tachycardia, etc).
* The participant has active liver disease or hepatic dysfunction at screening or check-in visits.
* The participant has a history of human immunodeficiency virus (HIV) infection.
* The participant has a history of abnormal bleeding or bruising.
* The participant has a history of malignancy in the past 5 years, with exception of nonmelanoma skin cancer.
* The participant has a current history (within the past 12 months) of substance and/or alcohol abuse.
* The participant is a current user of cigarettes (average of ≥1 cigarette/day) or e-cigarettes within 30 days prior to screening.
* The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug or throughout the study.

Note: Other inclusion/exclusion criteria may apply.

**Healthy Volunteers:** True

**Maximum Age:** 45 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Austin

**Country:** United States

**Facility:** USA001

**State:** Texas

**Zip:** 78744

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Ismat FA, Usansky HH, Villa R, Zou J, Teper A. Safety, Tolerability, and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder for Pulmonary Hypertension: A Phase 1, Randomized, Double-Blind, Single- and Multiple-Dose Study. Adv Ther. 2022 Nov;39(11):5144-5157. doi: 10.1007/s12325-022-02296-x. Epub 2022 Sep 7.

**PMID:** 36070132

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012120

- Term: Respiration Disorders

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27137

- Name: Respiratory Aspiration

- Relevance: HIGH

- As Found: Inhalation

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000053120

- Term: Respiratory Aspiration

### Intervention Browse Module - Ancestors

- ID: D000000959

- Term: Antihypertensive Agents

### Intervention Browse Module - Browse Branches

- Abbrev: AnAg

- Name: Antihypertensive Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M255601

- Name: Treprostinil

- Relevance: HIGH

- As Found: Push

- ID: M4277

- Name: Antihypertensive Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000427248

- Term: Treprostinil

### Misc Info Module

- Version Holder: 2024-05-24
