Phase 1 Study of Intravaginal KB15A

NCT07222020 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: KB15A-015P50HD096957-08
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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 findings

  From baseline through study completion, on average 3-4 months

• Number of Participants With Abnormal Laboratory Values

  From baseline through study completion, on average 3-4 months

Secondary Outcomes (2)

• Mass of anti-sperm-antibody in the vagina

  Baseline; 30 minutes, 1, 2 and, 4 hours after first single dose; 30 minutes and 8 or 48 hours after second single dose; 1, 4, 8 and 24 hours after first multi-dose; and 24 hours and 5 - 8 days after final multi-dose.

• Concentration of anti-sperm-antibody in serum

  Baseline; 48 hours after first single dose; 48 hours after second single dose; and 24 hours after final multi-dose

Study Arms (2)

KB15A

EXPERIMENTAL

KB15A (Vaginal Film)

Drug: KB15A Vaginal Film

Placebo

PLACEBO COMPARATOR

Placebo (Vaginal Film)

Drug: Placebo Vaginal Film

Interventions

KB15A Vaginal Film DRUG

KB15A is a polyvinyl-alcohol based intravaginal film containing the KB15A.16.2 monoclonal antibody.

KB15A

Placebo Vaginal Film DRUG

The Placebo is a polyvinyl-alcohol based intravaginal film composed identically to the KB15A Vaginal Film, but without the KB15A.16.2 monoclonal antibody.

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Old Dominion University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• ZabBio Inc.: lead
• Boston University: collaborator

Study Sites (1)

Virginia Health Sciences at Old Dominion University

Norfolk, Virginia, 23507, United States

RECRUITING

Central Study Contacts

Kristin Ayers

CONTACT

757-446-0529; ayerskl@odu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-Controlled, Double-Blinded, Randomized, Interventional

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)