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NCT07225296 · ClinicalTrials.gov registry record · Phase 1
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants
A Phase 1 study of Idiopathic Pulmonary Fibrosis, sponsored by Genosco.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT07225296: Recruiting Phase 1 study of Idiopathic Pulmonary Fibrosis, sponsored by Genosco.
NCT07225296 is a Phase 1 study of Idiopathic Pulmonary Fibrosis that is actively recruiting participants, run by Genosco. The registered enrollment target is 72 participants, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225296, a Phase 1 study of Idiopathic Pulmonary Fibrosis, is actively recruiting participants, sponsored by Genosco.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Number and severity of treatment-emergent adverse events (TEAEs) following single and multiple doses of GNS-3545 and placebo
Conditions Studied
Interventions
- DRUG GNS-3545
- DRUG GNS-3545 Placebo
Study Locations (1)
Maryland
- Pharmaron CPC, Inc. - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2025-11-12 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 1 |
What NCT07225296 shows while recruiting
NCT07225296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Idiopathic Pulmonary Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which GNS-3545 is the first listed.
NCT07225296 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07225296 about?
NCT07225296 is a clinical study titled "A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants". 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.
What is the current status of trial NCT07225296?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2025-11-12. Estimated completion is 2026-10-31.
What conditions does trial NCT07225296 study?
This clinical trial studies the following conditions: Idiopathic Pulmonary Fibrosis.
What interventions are being tested in trial NCT07225296?
The interventions under investigation include: GNS-3545 (DRUG), GNS-3545 Placebo (DRUG).
Who is sponsoring clinical trial NCT07225296?
This trial is sponsored by Genosco, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07225296 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Idiopathic Pulmonary Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07225296's enrollment target sits among peer trials
72 23rd of 51 higher than 29 of 51 other Idiopathic Pulmonary Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Idiopathic Pulmonary Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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