Clinical Trial

A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants

Completed Phase 1
View on ClinicalTrials.gov →
Summary
This is a randomized, double-blind, placebo-controlled Phase 1 study of SAD (Part 1) and MAD (Part 2) of orally administered GNS-3545 in healthy adult subjects. The food effect will be assessed in one cohort in Part 1.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-11-04; most recent amendment 2026-07-16.
Status change: Recruiting → Completed 2026-07-16
Trial Details
NCT Number NCT07225296
Lead Sponsor Genosco Inc.
Conditions Idiopathic Pulmonary Fibrosis
Enrollment 63 participants
Start Date 2025-11-12
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-17