Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • KB15A Vaginal Film

    Drug

    KB15A is a polyvinyl-alcohol based intravaginal film containing the KB15A.16.2 monoclonal antibody.

  • Placebo Vaginal Film

    Drug

    The Placebo is a polyvinyl-alcohol based intravaginal film composed identically to the KB15A Vaginal Film, but without the KB15A.16.2 monoclonal antibody.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: KB15AExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures.

Time frame
From baseline through study completion, on average 3-4 months
2

Change in colposcopic findings

Time frame
From baseline through study completion, on average 3-4 months
3

Number of Participants With Abnormal Laboratory Values

Time frame
From baseline through study completion, on average 3-4 months

Secondary outcomes

1

Mass of anti-sperm-antibody in the vagina

Mass of anti-sperm-antibody in the cervicovaginal fluid from vaginal swabs and cervicovaginal fluid lavage (CVL) supernatant.

Time frame
Baseline; 30 minutes, 1, 2 and, 4 hours after first single dose; 30 minutes and 8 or 48 hours after second single dose; 1, 4, 8 and 24 hours after first multi-dose; and 24 hours and 5 - 8 days after final multi-dose.
2

Concentration of anti-sperm-antibody in serum

Time frame
Baseline; 48 hours after first single dose; 48 hours after second single dose; and 24 hours after final multi-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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