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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Accepted

Interventions

• YASO GEL — DRUG
  Contraceptive gel
• Placebo gel — DRUG
  Inactive placebo gel matching the investigational contraceptive

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Dec 2025

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Lead-in study
  Participants receive a single low dose of the investigational contraceptive to assess initial safety and tolerability.
• Experimental: Phase 1, Stage 1 - Active Drug
  Participants receive a single full-strength dose of the investigational contraceptive in a randomized, double-blind design.
• Placebo Comparator: Phase 1, Stage 1 - Placebo
  Participants receive a single dose of placebo in a randomized, double-blind design.
• Experimental: Phase 1, Stage 2 - Active Drug
  Participants receive daily full-strength doses of the investigational contraceptive for 7 days in a randomized, double-blind design.
• Placebo Comparator: Phase 1, Stage 2 - Placebo
  Participants receive daily placebo doses for 7 days in a randomized, double-blind design.
• Experimental: Coital Sub-study
  Participants receive full-strength investigational contraceptive in an open-label sub-study to further assess safety and exploratory endpoints.

Primary Outcome Measure

Incidence of treatment-emergent adverse events [ Time Frame: Incidence of treatment-emergent adverse events, measured from first dose through Day 3 post-dose (Lead-in), 21 days post-dose (Phase 1, Stage 1), 28 days post first dose (Phase 1, stage 2) and 24 hours post dose (coital sub-study). ]

Central Contacts

• Philippa Quy
  974-6694-9579
  [email protected]
• Mary Weitzel
  480-238-6117
  [email protected]

Locations (1)

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