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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 10 Dec 2025

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At a glance

  • Drugs GNS 3545 (Primary)
  • Indications Idiopathic pulmonary fibrosis
  • Focus Adverse reactions; First in man
  • Sponsors Genosco

Most Recent Events

  • 14 Nov 2025 New trial record
  • 03 Oct 2025 According to Genosco media release, the company plans to initiate clinical trials of GNS-3545 within the year 2025 and expects to confirm the safety and tolerability of GNS-3545 and maximize the commercialization potential of GNS-3545 through strategic collaborations and technology transfers with global pharmaceutical companies in the future.
  • 03 Oct 2025 According to Genosco media release, the FDA has approved its Phase 1 clinical trial plan (IND) for its idiopathic pulmonary fibrosis (IPF) treatment candidate, "GNS-3545." This approval comes approximately one month after the company submitted the IND to the FDA in late August.

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