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Phase 1 Clinical Evaluation of YASO Gel: Early Data on Safety and Pharmacokinetics in Women

December 15, 2025
H RA

Clinical research teams are preparing to launch a phase 1 study of a promising investigational product, YASO Gel. Designed for vaginal application, this gel is undergoing regulatory scrutiny to ensure robust safety and pharmacokinetics data. Sponsored by Yaso Therapeutics Corporation with contributions from NICHD and Magee-Women’s Research Institute, the study has not yet begun recruiting participants as of December 15, 2025.

YASO Gel represents a focused intervention targeted for vaginal health. Teams overseeing the research are set to adhere to regulatory protocols for safety monitoring, aiming to fulfill documentation requirements vital for eventual market authorization.

In this article:

What is the study about?

The upcoming clinical trial seeks to establish critical safety and pharmacokinetical data in an early clinical-stage setting. Specifically, YASO Gel’s application has been designed to address vaginal health conditions. This phase 1 setup will provide initial human exposure data, which is foundational for progressing to further clinical evaluation within the regulatory process.

The gel will be examined in comparison with a placebo, employing a double-blind randomized methodology. Clinical teams aim to minimize bias in outcomes, an integral part of data credibility. Findings from this study will likely serve as a key milestone for development, targeting eventual licensing or clearance based on global regulatory medical device standards.

Key study details

Initial details outlined include:

  • Study Design: Early-phase testing focused on both safety and pharmacokinetics.
  • Interventions: Comparison between YASO Gel and a placebo gel.
  • Recruitment Status: As of December 15, 2025, the study is not yet recruiting.

Participants will be monitored closely via protocol-defined endpoints. Furthermore, data gathered under strictly controlled conditions will be evaluated continuously to detect any adverse reactions or deviations from expected performance metrics.

The research initiative is sponsored by Yaso Therapeutics Corporation. Joining forces with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and Magee-Women’s Research Institute, the sponsor has assembled a comprehensive support system inclusive of both funding and institutional expertise.

Such collaborations reinforce the trial’s adherence to Good Clinical Practices (GCPs) and other regulatory compliance frameworks. The collective efforts of specialized institutions aim to ensure that study results meet the high threshold required for regulatory approval.

FAQ

  1. Why is YASO Gel being studied?
    YASO Gel is under investigation as a vaginal application designed for safety and pharmacokinetics monitoring, essential stages within regulatory pathways.
  2. Where can I track the study’s progress?
    You can monitor updates on ClinicalTrials.gov under the study identifier NCT07281404.
  3. How does this study differ from later phases?
    Phase 1 focuses primarily on initial safety data, contrasting with later phases that delve deeper into efficacy and broader population testing.

Closing thoughts

For professionals in clinical research, quality assurance, and regulatory compliance, this study highlights an important step in developing interventions for vaginal health. Monitoring updates for recruitment and subsequent trial activities will provide insights into how safety and pharmacokinetics shape future phases.

Disclaimer

The information provided here is intended for professional and educational purposes and does not constitute legal advice. Readers should consult their regulatory or legal teams for compliance confirmation regarding medical devices or study protocols.

Announcement Link

For full information about the announcement, see the link below.

https://clinicaltrials.gov/study/NCT07281404?term=medical+device