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

ClinicalTrials.gov ID: NCT07225296

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Official title

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Ascending Dose, and Food-effect Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GNS-3545 in Healthy Adult Subjects

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07225296
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Genosco Inc.; Industry
Enrollment: 63 participants

Conditions and interventions

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

GNS-3545 Drug
GNS-3545 Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 12, 2025 (Actual)
Primary completion: Jun 30, 2026 (Actual)
Completion: Jun 30, 2026 (Actual)
Last update posted: Jul 17, 2026

2025 – 2026

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Pharmaron CPC, Inc.	Baltimore	Maryland	21201	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07225296, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 17, 2026 · Synced Nov 12, 2026