Phase 1 Study of Intravaginal KB15A

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.

NCT Number	NCT07222020
Lead Sponsor	ZabBio Inc. Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Boston University, Old Dominion University
Conditions	Healthy Subjects
Enrollment	24 participants
Start Date	2026-01-01
Primary Completion	2026-09-01 (estimated)
Study Completion	2026-12-28 (estimated)
Updated on ClinicalTrials.gov	2025-12-17