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

NCT07281404 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Early-phase Safety and PK Study of a Vaginal Gel

Interventions

DRUG

YASO GEL

Contraceptive gel

DRUG

Placebo gel

Inactive placebo gel matching the investigational contraceptive

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Magee-Women's Research Institute

    collaborator OTHER

  • Yaso Therapeutics Corporation

    lead INDUSTRY

Principal Investigators

  • Beatrice Chen, MD MPH · UPMC Magee-Womens Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07281404 on ClinicalTrials.gov