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

Phase 1 Completed 42 enrolled Insmed Incorporated

RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start: 2020-09-17
Primary completion: 2021-01-12
Completion: 2021-01-12

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Treprostinil Palmitil	Small molecule	112.5 ug	Other
Subject	Treprostinil Palmitil	Small molecule	225 ug	Other
Subject	Treprostinil Palmitil	Small molecule	450 ug	Other
Subject	Treprostinil Palmitil	Small molecule	675 ug	Other

Indications

No indication recorded.