RecruitingPhase 1NCT07222020

Phase 1 Study of Intravaginal KB15A

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

Sponsor

ZabBio Inc.

Enrollment

24 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Subjects

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria14

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 Criteria17

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.

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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.