NCT07281404: PPCM-01

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

Not yet recruiting EARLY_PHASE1 Last updated 17 December 2025

What this trial tests

EARLY_PHASE1 trial testing YASO GEL in Early-phase Safety and PK Study of a Vaginal Gel in 72 participants. Not yet recruiting.

Timeline

1 April 2026

Primary endpoint
1 February 2028

1 February 2028

Quick facts

Lead sponsor	Yaso Therapeutics Corporation
Phase	EARLY_PHASE1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	72
Start date	1 April 2026
Primary completion	1 February 2028
Estimated completion	1 February 2028
Sites	1 location across United States

Drugs / interventions tested

• YASO GEL — full drug profile →
• Placebo gel

Conditions studied

• Early-phase Safety and PK Study of a Vaginal Gel — all drugs for Early-phase Safety and PK Study of a Vaginal Gel →

Sponsor

Yaso Therapeutics Corporation — full company profile →

Who can join

Adults 18 to 55, any sex, with Early-phase Safety and PK Study of a Vaginal Gel. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).
  Number, type, and severity of adverse events observed from first dose through end of follow-up per study section.
• Plasma and vaginal fluid concentrations of investigational contraceptive
  Time frame: Time from first dose to last PK sample collection per study section: lead-in up to Day 3; Phase 1 Stage 1 up to Day 21; Phase 1 Stage 2 up to Day 28; sub-study up to 24 hours post dose; samples collected at multiple predefined timepoints.
  Concentrations of the investigational contraceptive measured in blood plasma and vaginal fluid at predefined timepoints from first dose through last PK sample per study section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.