Overview

FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL

Status:
NOT_YET_RECRUITING

Trial end date:
2028-02-01

Target enrollment:

Participant gender:

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.

Phase:

EARLY_PHASE1

Details

Lead Sponsor:

Yaso Therapeutics Corporation

Collaborators:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Magee-Women's Research Institute