Phase 1 Study of Intravaginal KB15A
This study is testing KB15A, a vaginal film containing an antibody designed to prevent pregnancy by trapping sperm. Researchers want to see if KB15A is safe and how it moves through your body. You could be eligible if you are a healthy woman between 18 and 45 years old and are using an approved birth control method or abstaining from sex. The study will compare KB15A to a placebo (an inactive film) to look for side effects and understand how the antibody is distributed locally and in your system. The main goals are to check for any negative effects and changes in laboratory results over about 3-4 months.
- Study design
- This is an interventional study planning to enroll 24 healthy women. It compares KB15A vaginal film to a placebo vaginal film.
- What's involved
- You would receive two single doses of either KB15A or placebo vaginal film, and later 14 daily doses of either film. Assessments will occur from baseline through study completion, averaging 3-4 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed from baseline through study completion, which is on average 3-4 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07222020
Phase 1 Study of Intravaginal KB15A
Recruiting
PHASE1Ages 18–45InterventionalPreventionZabBio Inc.
~24 participants
Updated 2025-12-17 on ClinicalTrials.gov
What's tested:KB15A Vaginal FilmPlacebo Vaginal Film
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures.
Measured over From baseline through study completion, on average 3-4 months
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesVirginia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures.From baseline through study completion, on average 3-4 months
- Change in colposcopic findingsFrom baseline through study completion, on average 3-4 months
- Number of Participants With Abnormal Laboratory ValuesFrom baseline through study completion, on average 3-4 months