Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT07281404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL
Sponsor:
Yaso Therapeutics Corporation
Organization:
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPCM-01
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.
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.
Detailed Description:
This study initiates with a first-in-human lead-in study using a subtherapeutic 0.7% dose of YASO GEL. The study aims to provide a preliminary assessment of PPCM pharmacokinetics in plasma and vaginal fluid, and to validate a bioanalytical assay to be used to measure efficacy in both the Phase 1 and sub studies. Data from this study will help ensure that pharmacokinetic sampling is adequate for subsequent clinical trials and will provide initial safety information to support a Phase 1 study.
The subsequent randomized double-blind Phase 1 study will use a therapeutic 2.0% dose of YASO GEL administered once in Stage 1 of the Phase 1 study and once daily for 7 days in Stage 2 of the Phase 1 study. The Phase 1 study is designed to provide comprehensive baseline safety and pharmacokinetic data in a dose response manner. As such, it is important to assess the genitalia (vulva, perineum and vagina for female participants and penis, scrotum, and perineum for male participants) after each dose for safety, initially with single dose and then with repeated dosing. Because it is anticipated that a coitally-dependent product will be applied prior to each act of coitus, and individuals may have coitus more than once a day, future studies will evaluate more frequent dosing and further characterize the YASO GEL safety profile.
Secondarily, acceptability and adherence data will be collected to inform future product design and patient education. Exploratory endpoints include assessment of vaginal fluid samples for vaginal microbiome, soluble immune mediators, ex-vivo contraceptive activity and anti-microbial activity against both HIV and Ng.
A sub-study is included to evaluate the impact of coitus on safety and pharmacokinetics of YASO GEL use. This study will also collect acceptability and adherence data to inform future product design and patient education. Vaginal fluid samples will be assessed for contraceptive activity and ex vivo anti-microbial activity against both HIV and Ng, in an exploratory fashion to inform future study design.
The study will include healthy adult participants. Female participants will apply the gel internally in all studies. Male participants will apply the gel externally in the Lead-in and Phase 1 studies and be exposed to the gel in the coital sub-study. The results from this study will guide the design of future studies and help establish the safety and efficacy profile of YASO GEL in humans.
The subsequent randomized double-blind Phase 1 study will use a therapeutic 2.0% dose of YASO GEL administered once in Stage 1 of the Phase 1 study and once daily for 7 days in Stage 2 of the Phase 1 study. The Phase 1 study is designed to provide comprehensive baseline safety and pharmacokinetic data in a dose response manner. As such, it is important to assess the genitalia (vulva, perineum and vagina for female participants and penis, scrotum, and perineum for male participants) after each dose for safety, initially with single dose and then with repeated dosing. Because it is anticipated that a coitally-dependent product will be applied prior to each act of coitus, and individuals may have coitus more than once a day, future studies will evaluate more frequent dosing and further characterize the YASO GEL safety profile.
Secondarily, acceptability and adherence data will be collected to inform future product design and patient education. Exploratory endpoints include assessment of vaginal fluid samples for vaginal microbiome, soluble immune mediators, ex-vivo contraceptive activity and anti-microbial activity against both HIV and Ng.
A sub-study is included to evaluate the impact of coitus on safety and pharmacokinetics of YASO GEL use. This study will also collect acceptability and adherence data to inform future product design and patient education. Vaginal fluid samples will be assessed for contraceptive activity and ex vivo anti-microbial activity against both HIV and Ng, in an exploratory fashion to inform future study design.
The study will include healthy adult participants. Female participants will apply the gel internally in all studies. Male participants will apply the gel externally in the Lead-in and Phase 1 studies and be exposed to the gel in the coital sub-study. The results from this study will guide the design of future studies and help establish the safety and efficacy profile of YASO GEL in humans.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R44HD118927-01 | NIH | None | https://reporter.nih.gov/quic… | View |