Recruiting
Phase 1

KB15A

Sponsor:

ZabBio Inc.

Code:

NCT07222020

Conditions

Healthy Subjects

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

KB15A Vaginal Film

Placebo Vaginal Film

Study Details

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.

Conditions

Healthy Subjects

Study ID

NCT07222020

Start date

Dec 16, 2025

Status verified date

Apr, 2026

Completion date

Dec 28, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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 cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection.
  • Must be protected from pregnancy by:

  • Sterilization of either partner
  • Heterosexual abstinence
  • Hormonal contraceptives (except for the contraceptive vaginal ring)
  • Copper IUD
  • If in a relationship, must be in a mutually monogamous relationship with a partner who is not known to be HIV positive and has no known risk of sexually transmitted infections (STIs)

Exclusion Criteria:

  • 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,
  • Current symptomatic bacterial vaginosis (BV)
  • Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting/bleeding, discharge, etc.)
  • Significant gynecological abnormalities (including abnormal vaginal bleeding, excessive vaginal discharge, or vulvar/vaginal pain or irritation)
  • Current symptomatic UTI or vaginal candidiasis
  • History of sensitivity/allergy to KB15A film components, for either the volunteer
  • Less than 14 days since use of oral or vaginal antibiotics
  • Women with a history of genital herpes or condylomata who have been symptomatic in the last six months.
  • Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for an STI
  • Known current drug or alcohol abuse which could affect study compliance.
  • Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study
  • History of gynecological procedures (including genital piercing) on the external genitalia, vagina or cervix within the last 14 days
  • Abnormal finding on laboratory or physical examination or a social or medical condition in the participant, which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data.
  • Grade 2 or higher laboratory abnormality, per the 2014 update of the Division of AIDS, National Institute of Allergy and Infectious Disease (DAIDS) Table for Grading the Severity of Adverse Events, or clinically significant laboratory abnormality as determined by the clinician.

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: KB15A

KB15A (Vaginal Film)

placebo comparator: Placebo

Placebo (Vaginal Film)

Interventions

KB15A Vaginal Film

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

Placebo 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.

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 ]
  • Change in colposcopic findings [ Time Frame: From baseline through study completion, on average 3-4 months ]
  • Number of Participants With Abnormal Laboratory Values [ Time Frame: From baseline through study completion, on average 3-4 months ]

Central Contacts and Locations

Central contacts

Kristin Ayers

757-446-0529ayerskl@odu.edu

Locations

Virginia Health Sciences at Old Dominion University

Recruiting

Norfolk, Virginia, United States, 23507

More Information

Sponsor

ZabBio Inc.

Last update posted

Sep 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ZabBio Inc. on 2026-09-01.