Healthy SubjectsPhase 1NCT07222020
Phase 1 Study of Intravaginal KB15A
A Phase 1 study testing KB15A Vaginal Film in people with Healthy Subjects, run by ZabBio Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- KB15A Vaginal Film
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2025to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.)
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Health Sciences at Old Dominion University
Norfolk, Virginia, 23507
About this study
Official title: Phase 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
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.
Read the detailed description
KB15A is a polyvinyl-alcohol (PVA) based intravaginal contraceptive film Drug Product manufactured by KBio, Inc. containing the KB15A.16.2 Drug Substance. KB15A.16.2 is an IgG1 monoclonal antibody that targets CD52g, a unique glycan present on the surface of human sperm. KB15A is thought to work as a contraceptive by binding and trapping sperm in the vagina, so that they cannot migrate past the cervix and fertilize an oocyte.
This study will determine whether the KB15A film is safe in healthy women 18 - 45 years of age; it will also determine where the KB15A antibody is distributed in the body after film use. Participants must not be at risk of pregnancy due to one of the following approved methods of contraception or abstinence:
- prior surgical sterilization of self or sexual partner
- oral contraceptive pills
- transdermal patch
- contraceptive injection
- hormonal intrauterine system (IUS)
- heterosexual abstinence, or
- copper intrauterine device
Participants will be assessed for the genital, mucosal and systemic safety and pharmacokinetics of KB15A in two sequential study phases, separated by an approximately 2 - 6 week wash out period:
- A preliminary single-dose phase of the study where participants will receive two single doses of either KB15A or placebo vaginal film, separated by approximately 1 week;
- A multiple-dose phase of the study where participants will receive 14 consecutive daily doses of either KB15A or placebo vaginal film.
For the primary objective of the study, participants will be evaluated for Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures, changes in colposcopic findings, and changes in systemic laboratories (e.g. complete blood count, chemistry panel) after two single doses in the single dose phase, and again after 14 daily doses in the multiple dose phase.
The secondary objective of the study is to describe the concentration of monoclonal antibody locally in the cervicovaginal mucosa, and systemically in the blood. Pharmacokinetics will be measured at baseline and at 30 minutes and 1, 2, and 4 hours after the first single dose; at 30 minutes and 8 or 48 hours after the second single dose (depending on the pharmacokinetic sampling time point randomization assignment); at 1, 4, 8, and 24 hours after the 1st dose of film in the multiple dose phase; and 24 hours after the 14th dose in the multiple dose phase. Finally, pharmacokinetics will be measured 5 - 8 days after the 14th dose of the film in the multiple-dose phase.
- Conditions
- Healthy Subjects
- Being tested
- KB15A Vaginal Film, Placebo Vaginal Film
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB15A Vaginal FilmDrug
KB15A is a polyvinyl-alcohol based intravaginal film containing the KB15A.16.2 monoclonal antibody.
Placebo Vaginal FilmDrug
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 group | Role | What they receive |
|---|---|---|
| KB15A | Experimental | KB15A (Vaginal Film) Receives: Drug: KB15A Vaginal Film |
| Placebo | Placebo comparator | Placebo (Vaginal Film) Receives: Drug: Placebo Vaginal Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures.
Measured: From baseline through study completion, on average 3-4 months
Change in colposcopic findings
Measured: From baseline through study completion, on average 3-4 months
Number of Participants With Abnormal Laboratory Values
Measured: From baseline through study completion, on average 3-4 months
Secondary outcomes (2)
Mass of anti-sperm-antibody in the vagina
Mass of anti-sperm-antibody in the cervicovaginal fluid from vaginal swabs and cervicovaginal fluid lavage (CVL) supernatant.
Measured: 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
Measured: Baseline; 48 hours after first single dose; 48 hours after second single dose; and 24 hours after final multi-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start16 Dec 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-Controlled, Double-Blinded, Randomized, Interventional
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZabBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Boston University, Old Dominion University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222020
- Sponsor's protocol ID
- KB15A-01
- Other IDs
- 5P50HD096957-08
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2025
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 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
- ClinicalTrials.gov ID
- NCT07222020
- Acronym / sponsor ID
- KB15A-01
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- ZabBio Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Boston University, Old Dominion University
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
KB15A is a polyvinyl-alcohol (PVA) based intravaginal contraceptive film Drug Product manufactured by KBio, Inc. containing the KB15A.16.2 Drug Substance. KB15A.16.2 is an IgG1 monoclonal antibody that targets CD52g, a unique glycan present on the surface of human sperm. KB15A is thought to work as a contraceptive by binding and trapping sperm in the vagina, so that they cannot migrate past the cervix and fertilize an oocyte.
This study will determine whether the KB15A film is safe in healthy women 18 - 45 years of age; it will also determine where the KB15A antibody is distributed in the body after film use. Participants must not be at risk of pregnancy due to one of the following approved methods of contraception or abstinence:
- prior surgical sterilization of self or sexual partner
- oral contraceptive pills
- transdermal patch
- contraceptive injection
- hormonal intrauterine system (IUS)
- heterosexual abstinence, or
- copper intrauterine device
Participants will be assessed for the genital, mucosal and systemic safety and pharmacokinetics of KB15A in two sequential study phases, separated by an approximately 2 - 6 week wash out period:
- A preliminary single-dose phase of the study where participants will receive two single doses of either KB15A or placebo vaginal film, separated by approximately 1 week;
- A multiple-dose phase of the study where participants will receive 14 consecutive daily doses of either KB15A or placebo vaginal film.
For the primary objective of the study, participants will be evaluated for Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures, changes in colposcopic findings, and changes in systemic laboratories (e.g. complete blood count, chemistry panel) after two single doses in the single dose phase, and again after 14 daily doses in the multiple dose phase.
The secondary objective of the study is to describe the concentration of monoclonal antibody locally in the cervicovaginal mucosa, and systemically in the blood. Pharmacokinetics will be measured at baseline and at 30 minutes and 1, 2, and 4 hours after the first single dose; at 30 minutes and 8 or 48 hours after the second single dose (depending on the pharmacokinetic sampling time point randomization assignment); at 1, 4, 8, and 24 hours after the 1st dose of film in the multiple dose phase; and 24 hours after the 14th dose in the multiple dose phase. Finally, pharmacokinetics will be measured 5 - 8 days after the 14th dose of the film in the multiple-dose phase.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-Controlled, Double-Blinded, Randomized, Interventional
| Arm | Type | Receives |
|---|---|---|
| KB15A | Experimental | Drug: KB15A Vaginal FilmKB15A (Vaginal Film) |
| Placebo | Placebo comparator | Drug: Placebo Vaginal FilmPlacebo (Vaginal Film) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KB15A Vaginal FilmKB15A is a polyvinyl-alcohol based intravaginal film containing the KB15A.16.2 monoclonal antibody. | Drug | KB15A |
| Placebo Vaginal FilmThe Placebo is a polyvinyl-alcohol based intravaginal film composed identically to the KB15A Vaginal Film, but without the KB15A.16.2 monoclonal antibody. | Drug | Placebo |
Primary outcome
Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures.
Time frame: From baseline through study completion, on average 3-4 months
Change in colposcopic findings
Time frame: From baseline through study completion, on average 3-4 months
Number of Participants With Abnormal Laboratory Values
Time frame: From baseline through study completion, on average 3-4 months
2 secondary outcomes
Mass of anti-sperm-antibody in the vagina
Time frame: 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
Time frame: Baseline; 48 hours after first single dose; 48 hours after second single dose; and 24 hours after final multi-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KB15A Vaginal Film in people with Healthy Subjects, run by ZabBio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Ayers (757-446-0529, ayerskl@odu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs) and relatedness of TEAEs to study product or study procedures. (time frame: From baseline through study completion, on average 3-4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.