Safety and dosing of oral GNS-3545 in healthy adults
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
This trial will test whether different single and multiple oral doses of GNS-3545 are safe and how the drug behaves in the body in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Genosco Inc. Industry-sponsored |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT07225296 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled Phase 1 study tests single ascending dose (SAD) and multiple ascending dose (MAD) regimens of oral GNS-3545 in healthy adults. Part 1 includes SAD cohorts with one cohort assessing a food effect, and Part 2 includes MAD cohorts to characterize repeat-dose safety and pharmacokinetics/pharmacodynamics. Participants are randomized to GNS-3545 or placebo and dosed sequentially in ascending cohorts with safety review between cohorts. Safety, tolerability, ECGs, laboratory tests, and intensive PK/PD sampling are the primary data collected.
Who should consider this trial
Good fit: Healthy adults aged 18–55, continuous non-smokers, BMI 18–32 kg/m2, weighing at least 50 kg, and females of non-childbearing potential who can comply with study procedures are the intended participants.
Not a fit: Patients with active idiopathic pulmonary fibrosis or other significant medical or psychiatric conditions will not receive direct therapeutic benefit from this healthy-volunteer safety study.
Why it matters
Potential benefit: If successful, this work could enable development of a new oral treatment option for idiopathic pulmonary fibrosis by supporting later-phase efficacy trials.
How similar studies have performed: SAD/MAD Phase 1 designs are standard for first-in-human small-molecule programs and have supported development of other IPF-targeted drugs, but GNS-3545 itself appears to be an early, novel candidate with no public human efficacy data yet.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland
- Pharmaron CPC, Inc. — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: GNS-3545 Study Team
- Email: GNS_Clinical@genosco.com
- Phone: 617-494-1460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.