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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 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.

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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.

Conditions Studied

Idiopathic Pulmonary Fibrosis

Interventions

  • DRUG GNS-3545
  • DRUG GNS-3545 Placebo

Study Locations (1)

Maryland

  • Pharmaron CPC, Inc. - Baltimore

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2025-11-12
Est. Completion 2026-10-31
Phase Phase 1

Sponsor

Genosco

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07225296

The ClinicalTrials.gov registry entry for NCT07225296 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 750-participant average among 51 other Idiopathic Pulmonary Fibrosis trials with a reported enrollment target (90% lower). The listed sponsor is Genosco, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.