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Single Ascending Dose Study for Evaluation of Safety, Tolerability and Pharmacokinetics of L606

Pulmonary Arterial Hypertension Clinical Trial

Official title:
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of L606 for Inhalation in Healthy Subjects

Clinical Trial Summary

The primary objective of this study is to evaluate the Pharmacokinetics, Safety and Tolerability of L606 (Liposomal Treprostinil) Inhalation Solution in Single Ascending Dose study design in healthy volunteers.

Clinical Trial Description

L606 (Liposomal Treprostinil) Inhalation Solution and dedicated inhalation system is developed by Pharmosa Biopharm Inc. intended to improve the inconvenience, as one of the greatest impediments to patient satisfaction to current inhaled treprostinil therapy. Pharmosa's liposomal technology offers sustained release of treprostinil which enable bid treatment instead of conventional qid treatment offered by current inhaled treprostinil therapy for treatment of patients with PAH (WHO Group 1). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04041648
Study type Interventional
Source Pharmosa Biopharm Inc.
Contact
Status Completed
Phase Phase 1
Start date November 9, 2018
Completion date May 12, 2020
View Details
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