Recruiting

KB15A Vaginal Film Safety in Healthy Women

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-ControlledPhase 1

Interventional

Study Start: January 2026

See protocol details

Summary

Principal SponsorZabBio Inc.

Study ContactKristin Ayers

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2026

Actual 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: January 28, 2026

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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

10 inclusion criteria required to participate

Willing to give voluntary consent and sign an informed consent form.

Must be protected from pregnancy by: * Sterilization of either partner * Heterosexual abstinence * Hormonal contraceptives (except for the contraceptive vaginal ring) * Copper IUD

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.

Show More Criteria

17 exclusion criteria prevent from participating

Current symptomatic UTI or vaginal candidiasis

Participation in any other investigational trial within the last 30 days or planned participation in any other investigational trial during the study

Significant gynecological abnormalities (including abnormal vaginal bleeding, excessive vaginal discharge, or vulvar/vaginal pain or irritation)

Women with a history of genital herpes or condylomata who have been symptomatic in the last six months.

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)

Group II

Placebo

Placebo (Vaginal Film)

Study Objectives

Primary Objectives

Secondary Objectives

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 University

Norfolk, United StatesOpen Virginia Health Sciences at Old Dominion University in Google Maps

Recruiting

One Study Center