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 | Not Yet Recruiting Early Phase 1 DMC FDA Drug

• 2 other identifiers: PPCM-011R44HD118927-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Contraceptive activity; HIV prevention; Antimicrobial activity; Sexual activity; Vaginal gel; YASO GEL; Coital exposure; First-in-human; Mucosal drug delivery

Outcome Measures

Primary Outcomes (2)

• Incidence of treatment-emergent adverse events

  Number, type, and severity of adverse events observed from first dose through end of follow-up per study section.

  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).

• Plasma and vaginal fluid concentrations of investigational contraceptive

  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.

  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.

Secondary Outcomes (2)

• Acceptability Questionnaire

  Questionnaires administered at Day 2 post-dose during Phase 1, Stage 1 and on the final day of dosing, Day 7 during Phase 1, Stage 2 and immediately after intercourse on Day 3 of the coital sub-study.

• Adherence to dosing schedule

  Adherence based on self-reported use evidenced by participant diaries, device logs, or returned product counts post dosing on Day 1 and through Day 7 of the Phase 1, Stage 2 study.

Other Outcomes (10)

• Anti-viral Activity

  Pre and post-dose on Day 1, Day 2 and Day 7 of Phase 1, Stage 1 and after each coital visit during the sub-study.

• Anti-bacterial activity

  Pre and post-dose on Day 1, Day 2 and Day 7 of Phase 1, Stage 1 and after each coital visit during the sub-study.

• Hyaluronan Binding Assay (HBA) - Vaginal Fluid Exposed to Study Gel (Ex-Vivo)

  Pre and post dose day 1, Day 2 and Day 7 of Phase 1, Stage 1

Study Arms (6)

Lead-in study

EXPERIMENTAL

Participants receive a single low dose of the investigational contraceptive to assess initial safety and tolerability.

Drug: YASO GEL

Phase 1, Stage 1 - Active Drug

EXPERIMENTAL

Participants receive a single full-strength dose of the investigational contraceptive in a randomized, double-blind design.

Drug: YASO GEL

Phase 1, Stage 1 - Placebo

PLACEBO COMPARATOR

Participants receive a single dose of placebo in a randomized, double-blind design.

Drug: Placebo gel

Phase 1, Stage 2 - Active Drug

EXPERIMENTAL

Participants receive daily full-strength doses of the investigational contraceptive for 7 days in a randomized, double-blind design.

Drug: YASO GEL

Phase 1, Stage 2 - Placebo

PLACEBO COMPARATOR

Participants receive daily placebo doses for 7 days in a randomized, double-blind design.

Drug: Placebo gel

Coital Sub-study

EXPERIMENTAL

Participants receive full-strength investigational contraceptive in an open-label sub-study to further assess safety and exploratory endpoints.

Drug: YASO GEL

Interventions

YASO GEL DRUG

Contraceptive gel

Coital Sub-study; Lead-in study; Phase 1, Stage 1 - Active Drug; Phase 1, Stage 2 - Active Drug

Placebo gel DRUG

Inactive placebo gel matching the investigational contraceptive

Phase 1, Stage 1 - Placebo; Phase 1, Stage 2 - Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Only cisgender individuals with no history of gender reassignment impacting hormones or genital anatomy are eligible to participate
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Lead-in and Phase 1 Studies
• Adults who are:
• Women aged 18 through 45 years (inclusive)
• Men aged 18 years and over at Screening
• Cisgender individuals with no history of gender reassignment impacting hormones or genital anatomy
• Able to communicate in English
• Provide written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
• Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures.
• Provide adequate locator information (per site SOP)
• Understand and agree to local STI reporting requirements
• In general good health, in the opinion of the investigator
• Agree not to participate in other concurrent interventional and/or drug trials
• Female specific criteria:
• Women ≥ 21 years must have documentation of a satisfactory Pap within the past 3 years consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (Dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result. If result is not available, Pap test will be performed at screening.
• Regular menstrual cycles of approximately 21 to 35 days apart with no undiagnosed intermenstrual menstrual bleeding Note: This criterion is not applicable to participants using continuous combination oral contraceptive pills, patches, or progestin-only contraceptive methods (progestin-only pills, depot medroxyprogesterone acetate (DMPA), etonogestrel subdermal implant, or levonorgestrel-releasing IUD), as the absence of regular menstrual cycles and break-through bleeding are common in these contexts.

You may not qualify if:

• Lead-in and Phase 1 Study, as well as the Sub-Study Individuals who meet any of the following criteria will be excluded from the study
• Plans to relocate away from the study site area during the period of study participation
• Genital piercings and/or tattoos
• Have been diagnosed with genital HSV, with the first occurrence (initial episode) within three months prior to Screening
• Have had three or more outbreaks of genital HSV within the last year
• History of recurrent rash/dermatosis (e.g., eczema) in the genital area
• History of autoimmune disease
• History of adverse reaction to PPCM, methylparaben, propylparaben, hydroxypropyl methylcellulose (HPMC), or xanthan gum
• Known HIV seropositivity
• Non-therapeutic injection drug use in the 6 months prior to Screening
• Use of HIV PrEP or post-exposure prophylaxis within prior 6 months
• Use of systemic immunomodulatory medications within the 30 days prior to planned enrollment
• Participation in another research study involving drugs or medical devices within the 30 days prior to Enrollment
• Recent use (within last 14 days) and/or unwillingness to abstain from use of vaginally administered medications (including condoms containing Nonoxynol-9 \[N-9\]) for the duration of the study from enrollment through all follow up visits but not including periods between study phases.
• Laboratory abnormalities at screening:

Sponsors & Collaborators

• Yaso Therapeutics Corporation: lead
• Magee-Women's Research Institute: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

UPMC Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Sexual Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Beatrice Chen, MD MPH

  UPMC Magee-Womens Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippa Quy

CONTACT

974-6694-9579; pquy@yasotherapeutics.com

Mary Weitzel

CONTACT

480-238-6117; mweitzel@yasotherapeutics.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This first-in-human study consists of three parts. A 6-participant open-label lead-in cohort will receive a single low dose of the investigational contraceptive to assess initial safety and tolerability. The main Phase 1 study is a randomized, double-blind, parallel-group trial enrolling 32 participants, conducted in two stages: Stage 1 participants receive a single full-strength dose with 21-day follow-up, and Stage 2 participants receive daily full-strength doses for 7 days with 28-day follow-up. A 12-participant non-randomized coital sub-study will further assess safety and exploratory endpoints in the context of sexual activity, with and without use of the investigational product. Participants in the randomized Phase 1 portion remain in their assigned intervention arm throughout the study.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 15, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)