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

Insmed

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: Treprostinil Palmitil Inhalation Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT06091579

INS1009-102

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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42 participants in 5 patient groups

Part A (SAD Cohort 1): TPIP

Experimental group

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.

Treatment:

Drug: Treprostinil Palmitil Inhalation Powder

Part A (SAD Cohort 2): TPIP or Placebo

Experimental group

Description:

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

Treatment:

Drug: Treprostinil Palmitil Inhalation Powder

Drug: Placebo

Part A (SAD Cohort 3): TPIP or Placebo

Experimental group

Description:

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

Treatment:

Drug: Treprostinil Palmitil Inhalation Powder

Drug: Placebo

Part B (MAD Cohort 1): TPIP or Placebo

Experimental group

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.

Treatment:

Drug: Treprostinil Palmitil Inhalation Powder

Drug: Placebo

Part B (MAD Cohort 2): TPIP or Placebo

Experimental group

Description:

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

Treatment:

Drug: Treprostinil Palmitil Inhalation Powder

Drug: Placebo