A Three-part, Phase 1, Single and Multiple Ascending Dose Escalation and Food Effect Study in Healthy Participants to Assess the Safety, Tolerability, and Pharmacokinetics of QX-4533
QuantX Biosciences, Inc.
Summary
The primary purpose of this study is to evaluate the safety and tolerability of QX-4533 following oral administration of single and multiple ascending doses in healthy participants.
Description
This study will consist of 3 parts: Part 1: A randomized, double-blind, placebo-controlled single ascending dose (SAD) evaluation, including an open-label crossover food effect (FE) assessment in 1 cohort. Part 2: A 14-day randomized, double-blind, placebo-controlled multiple ascending dose (MAD) evaluation. Part 3: An open-label, 2-period crossover FE assessment.
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Male or female between 18 and 55 years of age (inclusive) at screening. * Understands the study procedures and is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. * Willing and able to comply with this protocol and be available for the entire duration of the study. * In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), c…
Interventions
- DrugQX-4533
QX-4533 tablets
- DrugPlacebo
QX-4533 matched-placebo tablets
Location
- 103 Carnegie CenterPrinceton, New Jersey