Phase 1 Study of Intravaginal KB15A

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2025
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.
Epistemonikos ID: 7caa5e93dc0f3bc4a640e8a7b1d1fff1eb377e96
First added on: Oct 30, 2025