Phase 1 Study of Intravaginal KB15A
ConditionHealthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorZabBio Inc.
About this trial
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
Qualifiers
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
Disqualifiers
History of hysterectomy
Currently pregnant
Currently breastfeeding or planning to breastfeed during the course of the study
Current Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
Trial design
Treatments tested in this trial
- KB15A Vaginal Film
- Placebo Vaginal Film
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
ZabBio Inc.
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Boston University
Collaborator
Old Dominion University
Collaborator
Source ClinicalTrials.gov