1
项与 Polyphenylene Carboxymethylene 相关的临床试验 / Not yet recruiting早期临床1期 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
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.
100 项与 Polyphenylene Carboxymethylene 相关的临床结果
100 项与 Polyphenylene Carboxymethylene 相关的转化医学
100 项与 Polyphenylene Carboxymethylene 相关的专利(医药)
100 项与 Polyphenylene Carboxymethylene 相关的药物交易