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

NCT07225296 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-11-25

No results posted yet for this 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

Interventions

DRUG

GNS-3545

GNS-3545 will be administered as oral tablets at assigned dose levels to six of the eight participants within each cohort in Part 1 (SAD) and Part 2 (MAD). In Part 1, participants will receive a single dose on one occasion (Day 1). In Part 2, participants will receive daily dosing for 14 consecutive days.

DRUG

GNS-3545 Placebo

The placebo will be administered as oral tablets identical in appearance to the GNS-3545 tablets to two of the eight participants within each cohort in Part 1 (SAD) and Part 2 (MAD). In Part 1, participants will receive a single placebo dose on one occasion (Day 1). In Part 2, participants will receive once-daily placebo doses for 14 consecutive days.

Sponsors & Collaborators

  • Genosco Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2026-06-12
Completion
2026-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225296 on ClinicalTrials.gov