NCT06091579

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Insmed Incorporated · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Treprostinil Palmitil Inhalation Powder	Oral inhalation using a Plastiape capsule-based dry powder inhaler.
DRUG	Placebo	Oral placebo inhalation using a Plastiape capsule-based dry powder inhaler.

Timeline

• Start date: 2020-09-17
• Primary completion: 2021-01-12
• Completion: 2021-01-12
• First posted: 2023-10-19
• Last updated: 2023-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study