Phase 1 Study of Intravaginal KB15A

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
ZabBio Inc.
Study ID
NCT07222020
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
Sep 1, 2026
Completion
Dec 28, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: KB15A
    KB15A (Vaginal Film)
  • Placebo Comparator: Placebo
    Placebo (Vaginal Film)

Primary Outcome Measure

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Health Sciences at Old Dominion UniversityNorfolkVirginia23507-

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Virginia Health Sciences at Old Dominion University· Norfolk, VA

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