U.S., Dec. 16 -- ClinicalTrials.gov registry received information related to the study (NCT07281404) titled 'FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL' on Dec. 10.
Brief 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 a...