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Phase 1 Study of Intravaginal KB15A
Sponsor: ZabBio Inc.
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-01-01
Completion Date
2026-12-28
Last Updated
2025-12-17
Healthy Volunteers
Yes
Conditions
Interventions
KB15A Vaginal Film
KB15A is a polyvinyl-alcohol based intravaginal film containing the KB15A.16.2 monoclonal antibody.
Placebo 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