Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GNS-3545 in Healthy Adults
Led by Genosco Inc. · Updated on 2025-11-25
72
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GNS-3545 in healthy adult volunteers aged 18 to 55. It is a randomized, double-blind, placebo-controlled Phase 1 study that includes single ascending dose (SAD) and multiple ascending dose (MAD) parts, with an additional assessment of the food effect on the drug in one group during Part 1. Participants in Part 1 will receive a single oral dose of GNS-3545 or matching placebo, while in Part 2, participants will take daily oral doses for 14 consecutive days. Each cohort includes six participants receiving GNS-3545 and two receiving placebo. The study monitors how the drug is processed in the body and its effects after single and multiple doses. During the study, participants will be closely observed for any treatment-emergent adverse events from dosing through follow-up periods. Pharmacokinetic measurements such as drug concentration over time, peak levels, and urine excretion will be collected at specified intervals. The total participation involves dosing days and additional monitoring days up to 17 days post-dosing, ensuring thorough safety and drug behavior assessment.
CONDITIONS
Brief 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 of non-childbearing potential
- Male subjects must follow contraception guidance
- Non-smoker for at least 3 months before dosing
- Body mass index between 18.0 and 32.0 kg/m2 and body weight at least 50 kg
- Medically healthy with no significant medical history or abnormal examination findings
- No clinically significant ECG abnormalities
- Able to understand and comply with study procedures
You will not qualify if you...
- Mentally or legally incapacitated or with significant emotional problems
- History or presence of significant medical or psychiatric conditions
- Recent surgery or live vaccination within 30 days before dosing
- History of alcohol or drug abuse within 2 years prior to dosing
- History or presence of liver impairment
- History or presence of significant cardiovascular issues or risk factors
- Risk factors for adverse events related to blood pressure decreases
- Allergic to study drug components or related compounds
- Allergy to non-latex band aids, adhesive dressing, or medical tape
- Females of childbearing potential, pregnant, or lactating
- Positive urine drug or serum alcohol tests
- Positive screening for HIV, hepatitis B or C, or recent significant infection
- Use of medications or substances affecting certain enzymes or heart rhythm within washout periods
- Inability to follow the on-study diet or swallow multiple tablets
- Recent blood or plasma donation beyond allowed limits
- Dietary restrictions preventing consumption of high-fat/high-calorie meals
- Participation in another clinical study within 30 days or 5 half-lives of prior product
- Any other reason deemed by the investigator to prevent participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single dose on Day 1 for Part 1; 14 consecutive days for Part 2
Participants receive either a single dose (Part 1) or daily doses for 14 consecutive days (Part 2) of the study drug or placebo.
1 visit for single dose group; daily visits for up to 14 days for multiple dose group
Duration - Up to 8 days after dosing ends for Part 1; up to 8 days after dosing ends for Part 2
Participants are monitored for safety and drug effects after dosing ends.
Visits during follow-up period for safety assessments
Trial Site Locations
Total: 1 location
1
Pharmaron CPC, Inc.
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
G
GNS-3545 Study Team
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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