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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: t
View:
• Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age
• Male subjects must follow protocol specified contraception guidance
• Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing
• BMI ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit and body weight of ≥ 50 kg
• Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, or vital signs, as deemed by the PI or designee
• No ECG findings of clinical significance as judged by the PI or qualified designee
• Understands the study procedures in the ICF and be willing and able to comply with the protocol
Locations
United States
Maryland
Pharmaron CPC, Inc.
RECRUITING
Baltimore
Contact Information
Primary
GNS-3545 Study Team
GNS_Clinical@genosco.com
617-494-1460
Time Frame
Start Date:2025-11-12
Estimated Completion Date:2026-10-31
Participants
Target number of participants:72
Treatments
Experimental: GNS-3545
Part 1 (SAD): Six participants will be randomized to receive a single dose of GNS-3545 at the assigned dose level, while two participants will receive matching placebo.~Part 2 (MAD): Six participants will be randomized to receive multiple doses of GNS-3545 at the assigned dose level once daily for 14 consecutive days, while two participants will receive matching placebo.
Placebo_comparator: GNS-3545 Placebo
Part 1 (SAD): Six participants will be randomized to receive a single dose of GNS-3545 at the assigned dose level, while two participants will receive matching placebo.~Part 2 (MAD): Six participants will be randomized to receive multiple doses of GNS-3545 at the assigned dose level once daily for 14 consecutive days, while two participants will receive matching placebo.