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KB15A Vaginal Film Safety in Healthy Women

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What is being tested

KB15A Vaginal Film

+ Placebo Vaginal Film
Drug
Who is being recruted

From 18 to 45 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Phase 1
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorZabBio Inc.
Study ContactKristin Ayers
Last updated: December 18, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2026Actual date on which the first participant was enrolled.

This study focuses on a new contraceptive method for women aged 18 to 45, using a vaginal film called KB15A. This film contains a special protein that targets human sperm, preventing them from moving past the cervix to fertilize an egg. The study aims to determine if this film is safe and to understand how the protein distributes in the body after use. This research is important as it could offer another contraceptive option for women, potentially enhancing family planning methods available today. Participants in the study will use the KB15A film or a placebo, which is an inactive substance, in two phases. First, they will try single doses of the film, and then they move to a phase with daily doses for two weeks. Researchers will check for any side effects, changes in health markers, and how much of the active protein is present in the body and cervicovaginal mucosa at different times. Safety is a priority, and the study carefully monitors for any adverse reactions to ensure the film's safe use. Participants will be monitored closely with various tests to assess these outcomes.

Official TitlePhase 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 
NCT07222020
Principal SponsorZabBio Inc.
Study ContactKristin Ayers
Last updated: December 18, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
24 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 45 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria
10 inclusion criteria required to participate
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

Show More Criteria

17 exclusion criteria prevent from participating
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,

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
KB15A (Vaginal Film)

KB15A is a polyvinyl-alcohol based intravaginal film containing the KB15A.16.2 monoclonal antibody.
Group II
Placebo
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.
Study Objectives
Primary Objectives

Secondary Objectives

Mass of anti-sperm-antibody in the cervicovaginal fluid from vaginal swabs and cervicovaginal fluid lavage (CVL) supernatant.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Virginia Health Sciences at Old Dominion UniversityNorfolk, United StatesSee the location
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One Study Center