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Safety, Tolerability and Pharmacokinetics of L608 in Healthy Adults

Pulmonary Arterial Hypertension Clinical Trial

Official title:
A Phase I, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of L608 for Inhalation in Healthy Subjects

Clinical Trial Summary

This is a Phase I, randomized, double-blinded, placebo-controlled single ascending dose, sequential-group study to evaluate the safety, tolerability, and PK of single ascending doses of L608 inhalation in healthy volunteers.

Clinical Trial Description

L608 inhalation Solution (L608) is developed by Pharmosa Biopharm Inc. (PBI) as a new liposomal Iloprost formulation for inhalation use in the treatment of patients with PAH (WHO Group 1). As a liposomal formulation of iloprost, L608 is intended to reduce the dosing frequency, as well as provide sustained and selective release along with achieving therapeutically relevant iloprost level. Meanwhile, L608 is expected to mitigate burst release related local irritation and systemic side effects (e.g., hypotension due to plasma peak) in clinical practice. This Phase I, randomized, double-blinded, placebo-controlled study will be conducted in healthy volunteers in Australia to evaluate the safety, tolerability, and pharmacokinetic of L608. The dose escalation design is applied in this study. The sentinel dosing design will be applied for all cohorts. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05938946
Study type Interventional
Source Pharmosa Biopharm Inc.
Contact Pei Kan, PhD
Phone 886-2782-7561
Email peikan@pharmosa.com.tw
Status Recruiting
Phase Phase 1
Start date August 30, 2023
Completion date June 30, 2024
View Details
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