Open-label Lead-in Study of Single-dose 0.7% YASO GEL Followed by a Phase 1 Randomized, Double-blind Dose-escalation Study to Assess Safety and Pharmacokinetics of 2% YASO GEL
Yaso Therapeutics Corporation
Summary
The goal of this clinical trial is to assess the safety and pharmacokinetics of YASO GEL in healthy adult participants. This is a first-in-human study designed to understand how the gel is absorbed and distributed in plasma and vaginal fluid, and to evaluate the methods used to measure drug levels in humans. The main questions the study aims to answer are: What is the preliminary safety and tolerability of YASO GEL at a subtherapeutic 0.7% dose? How is YASO GEL absorbed and distributed, and does sexual activity affect its pharmacokinetics? Participants will: Receive an application of YASO GEL. Provide blood and vaginal fluid samples for pharmacokinetic analysis. Participate in a sub-study evaluating the impact of sexual activity on safety and drug exposure. Additional information on product acceptability, adherence, and exploratory laboratory analyses will be collected to inform the design of future studies.
Description
This study initiates with a first-in-human lead-in study using a subtherapeutic 0.7% dose of YASO GEL. The study aims to provide a preliminary assessment of PPCM pharmacokinetics in plasma and vaginal fluid, and to validate a bioanalytical assay to be used to measure efficacy in both the Phase 1 and sub studies. Data from this study will help ensure that pharmacokinetic sampling is adequate for subsequent clinical trials and will provide initial safety information to support a Phase 1 study. The subsequent randomized double-blind Phase 1 study will use a therapeutic 2.0% dose of YASO GEL admi…