NCT04041648

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Pharmosa Biopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	L606 (Liposomal Treprostinil) Inhalation Solution 51ug	Single ascending dose
DEVICE	L606 Inhalation System	Single ascending dose
OTHER	Placebo Solution	Single ascending dose

Timeline

• Start date: 2018-11-09
• Primary completion: 2019-09-20
• Completion: 2020-05-12
• First posted: 2019-08-01
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study