Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * Age 18 to 45 years, inclusive * General good health (by volunteer history and per investigator judgment) without any clinically significant systemic disease (including, but not limited to significant liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease, and diabetes) and with an intact gastrointestinal tract, uterus and cervix. * History of regular menstrual cycles, by volunteer report, if not taking exogenous hormones * History of Pap smears and follow-up consistent with standard clinical practice as outlined in the Study Manual or willing to undergo a Pap smear at Visit 1 * Willing to give voluntary consent and sign an informed consent form. * Willing to use non-spermicidal, lubricated condoms for any vaginal intercourse according to the study protocol. * Willing to abstain from intercourse and use of intravaginal medications, lubricants, and other products as required in the protocol. * Vaginal and cer