RecruitingPhase 1NCT07222020

Phase 1 Study of Intravaginal KB15A

Phase I, Placebo-Controlled, Double-Blinded, Randomized, Interventional, Safety and Pharmacokinetic Study of Single and Multiple Dosing of KB15A, a Vaginal Film Containing KB15A, an Anti-Sperm Monoclonal Antibody


Sponsor

ZabBio Inc.

Enrollment

24 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to determine the safety and mucosal pharmacokinetics of KB15A, a vaginal film containing an anti-sperm monoclonal antibody, in healthy adult women. Researchers will compare KB15A use to placebo use, primarily to see if KB15A is associated with adverse events, and also to understand the local and systemic distribution of the KB15A monoclonal antibody following use of the vaginal film. Participants will be assessed for the genital, mucosal and systemic safety and pharmacokinetics of KB15A in a preliminary single-dose phase of the study, where they will receive two single doses of either KB15A or placebo vaginal film, and again in a multiple-dose phase of the study, where they will receive 14 daily doses of either KB15A or placebo vaginal film.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called KB15A Vaginal Film and a drug called Placebo Vaginal Film for people with healthy subjects. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKB15A Vaginal Film

KB15A is a polyvinyl-alcohol based intravaginal film containing the KB15A.16.2 monoclonal antibody.

DRUGPlacebo Vaginal Film

The Placebo is a polyvinyl-alcohol based intravaginal film composed identically to the KB15A Vaginal Film, but without the KB15A.16.2 monoclonal antibody.


Locations(1)

Virginia Health Sciences at Old Dominion University

Norfolk, Virginia, United States

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NCT07222020


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