KB15A vaginal film to test a non-hormonal contraceptive in healthy women

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

This trial tests whether a KB15A vaginal film is safe and how the antibody spreads locally and systemically when used by healthy women ages 18 to 45.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: ZabBio Inc. (Industry-sponsored)
• Locations: 1 site (Norfolk, Virginia)
• Trial ID: NCT07222020 on ClinicalTrials.gov

What this trial studies

KB15A is a polyvinyl-alcohol intravaginal film that delivers an IgG1 monoclonal antibody targeting a sperm-specific glycan (CD52g) and is designed to trap sperm in the vagina. The study is randomized and placebo-controlled and includes a single-dose phase (two doses about a week apart) followed by a multiple-dose phase (14 consecutive daily doses) separated by a 2–6 week washout. Researchers will monitor genital, mucosal, and systemic safety and measure local and systemic pharmacokinetics of the KB15A antibody. Eligible participants must be healthy women 18–45 who are not at risk of pregnancy because they use an approved contraceptive method or abstain.

Who should consider this trial

Good fit: Healthy women aged 18 to 45 who are not at risk of pregnancy because of approved contraception or abstinence and who can comply with study visit and product-use requirements are ideal candidates.

Not a fit: Women who are pregnant, breastfeeding, trying to conceive, outside the 18–45 age range, or with significant systemic illness or contraindicated reproductive anatomy are not eligible and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, KB15A could offer a non-hormonal, on-demand topical contraceptive that prevents sperm from reaching the cervix.

How similar studies have performed: This antibody-based vaginal contraceptive approach is relatively novel; preclinical studies and limited early-phase work with similar topical antibody products show promise but human data remain limited.

Eligibility criteria

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.

Where this trial is running

Norfolk, Virginia

• Virginia Health Sciences at Old Dominion University — Norfolk, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Kristin Ayers

Conditions Healthy Subjects