NCT07225296 · Genosco Inc.
A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GNS-3545 in Healthy Participants
What this study is about
This is a randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment Phase 1 study of SAD (Part 1) and MAD (Part 2) of taken by mouth administered GNS-3545 in healthy adult subjects. The food effect will be assessed in one group of participants in Part 1.
View original scientific description
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.
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.
Primary outcome measures
Treatment Emergent Adverse Events (TEAEs)
Time frame: Collection of TEAEs occurs from the point of first dose administration (Day 1 in each part) through to study completion (up to 8 days from the first dosing for Part 1 & up to 8 days from the last dosing for Part 2).
Number and severity of treatment-emergent adverse events (TEAEs) following single and multiple doses of GNS-3545 and placebo
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- Is mentally or legally incapacitated or has significant emotional problems
- History or presence of clinically significant medical or psychiatric conditions
- History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- Surgical procedure or Administration of a live vaccination within 30 days prior to the first dose of the study drug
- History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- History or presence of hepatic impairment
- History or presence of significant cardiovascular conditions or risk factors
- Subjects with a higher risk of adverse events in the setting of blood pressure decreases
- History or presence of hypersensitivity to compounds related to the study drug excipients
- Allergy to non-latex band aids, adhesive dressing, or medical tape
- Female subjects of childbearing potential or Female subject with a positive pregnancy test or who is lactating
- Positive urine drug or serum alcohol results
- Positive results at the screening visit for HIV, HBsAg, or HCV, or a clinically significant history of infection within 3 months prior to screening
- Inability or unwillingness to avoid use of medications, supplements, or substances that may affect CYP enzymes, drug transporters, blood pressure, or QT/QTc interval within the specified washout periods prior to dosing
- Has been on a diet incompatible with the on-study diet, or unable to swallow multiple tablets by mouth
- Has donated or lost more than 500 mL of blood within 56 days prior to the first dosing, or Plasma donation within 7 days prior to the first dosing
- Subjects with dietary restrictions that would prevent subjects from consuming a high-fat/high-calorie meal
- Participation in another clinical study within 30 days or 5 half-lives of the product prior to the first dosing
- Any reason determined by the PI or designee, in their opinion, that would prevent the subject's participation in the study
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 25, 2025 · Source of record for eligibility and locations