Actively Recruiting
Phase 1 Study of Intravaginal KB15A
Led by ZabBio Inc. · Updated on 2025-12-17
24
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
Z
ZabBio Inc.
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Phase 1 Study of Intravaginal KB15A
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 45 years, inclusive
- General good health without significant systemic diseases
- Intact gastrointestinal tract, uterus, and cervix
- Regular menstrual cycles if not using hormones
- History of Pap smears consistent with standard care or willing to have a Pap smear at Visit 1
- Willing to give informed consent
- Willing to use non-spermicidal lubricated condoms for vaginal intercourse as per protocol
- Willing to abstain from intercourse and intravaginal products as required
- Vaginal and cervical anatomy suitable for sample collection
- Protected from pregnancy by sterilization, heterosexual abstinence, hormonal contraceptives (except vaginal ring), or copper IUD
- If in a relationship, must be mutually monogamous with a partner without known HIV or STI risk
You will not qualify if you...
- History of hysterectomy
- Currently pregnant
- Currently breastfeeding or planning to breastfeed during the study
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis
- Current symptomatic bacterial vaginosis
- Chronic or acute vulvar or vaginal symptoms like pain, irritation, bleeding, or discharge
- Significant gynecological abnormalities
- Current symptomatic urinary tract infection or vaginal candidiasis
- Known allergy or sensitivity to KB15A film components
- Use of oral or vaginal antibiotics within the last 14 days
- History of genital herpes or condylomata with symptoms in last six months
- Deep genital epithelial injuries or suspicious vesicles for STI
- Current drug or alcohol abuse affecting compliance
- Participation in other investigational trials within last 30 days or planned during study
- Gynecological procedures on external genitalia, vagina, or cervix within last 14 days
- Abnormal laboratory or physical findings making participation unsafe
- Grade 2 or higher laboratory abnormalities per DAIDS guidelines or clinically significant abnormalities
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Virginia Health Sciences at Old Dominion University
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
K
Kristin Ayers
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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