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
Genosco Inc.
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
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugGNS-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.
- DrugGNS-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.
Location
- Pharmaron CPC, Inc.Baltimore, Maryland