Actively Recruiting
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants
Led by Genosco Inc. · Updated on 2025-11-25
72
Participants Needed
1
Research Sites
50 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 55 years, male or female (non-childbearing potential only)
- Male participants must follow contraception guidelines
- Continuous non-smoker with no nicotine use for at least 3 months before dosing
- Body mass index between 18.0 and 32.0 kg/m2 and body weight of at least 50 kg
- Medically healthy with no significant medical history, physical exam, lab tests, or vital signs as judged by the investigator
- No clinically significant ECG findings
- Understands and agrees to study procedures and able to comply with the protocol
You will not qualify if you...
- Mentally or legally incapacitated or significant emotional problems
- History or presence of significant medical or psychiatric conditions
- Any illness that could affect study results or increase risk as judged by the investigator
- Surgery or live vaccination within 30 days before first dose
- Alcohol or drug abuse within 2 years before dosing
- History or presence of liver impairment
- Significant cardiovascular conditions or risk factors
- Risk for adverse events from blood pressure decreases
- Hypersensitivity to study drug or excipients
- Allergy to non-latex band aids, adhesive dressings, or medical tape
- Female of childbearing potential, pregnant, or lactating
- Positive urine drug or alcohol tests
- Positive HIV, HBsAg, or HCV tests or recent significant infections
- Unable or unwilling to avoid medications/supplements affecting CYP enzymes, blood pressure, or QT/QTc interval
- Unwilling or unable to follow on-study diet or swallow multiple tablets
- Blood donation of more than 500 mL within 56 days or plasma donation within 7 days before dosing
- Dietary restrictions preventing high-fat/high-calorie meal consumption
- Participation in another clinical study within 30 days or 5 half-lives before dosing
- Any other reason the investigator deems unsuitable for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Pharmaron CPC, Inc.
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
G
GNS-3545 Study Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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