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
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.
Description
KB15A is a polyvinyl-alcohol (PVA) based intravaginal contraceptive film Drug Product manufactured by KBio, Inc. containing the KB15A.16.2 Drug Substance. KB15A.16.2 is an IgG1 monoclonal antibody that targets CD52g, a unique glycan present on the surface of human sperm. KB15A is thought to work as a contraceptive by binding and trapping sperm in the vagina, so that they cannot migrate past the cervix and fertilize an oocyte. This study will determine whether the KB15A film is safe in healthy women 18 - 45 years of age; it will also determine where the KB15A antibody is distributed in the bod…
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- Yes
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 i…
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.
Location
- Virginia Health Sciences at Old Dominion UniversityNorfolk, Virginia