ContraceptionEarly Phase 1NCT04731818
An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film
A Early Phase 1 study testing ZB-06 in people with Contraception, run by KBio Inc at 1 site in United States.
Trial summary
This is an early Phase 1 study to establish proof-of-concept by determining whether an intravaginal film containing a human contraceptive antibody (ZB-06) shows promise to provide contraceptive efficacy using the post-coital test, a surrogate measure of efficacy. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- ZB-06
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2021to 24 Feb 2022
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 - 50 years, inclusive
- General good health, by volunteer history and per investigator judgment
- History of regular menstrual cycles of 21 - 35 days (inclusive), by volunteer report
- History of a normal PAP smear or ASCUS with negative HPV testing within the previous 12 months
- Willing to abstain from intercourse and use of vaginal medications, lubricants, and other products as required in the protocol
- Willing to use non-spermicidal, lubricated condoms for any vaginal intercourse from the first day of each menstrual cycle until 72 hours before expected midcycle
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- In a mutually monogamous relationship with a male partner who:
- Is at least 18 years old
- Has no known risk for sexually transmitted infections (STIs)
- Is willing and able to comply with protocol requirements including sexual activity/ abstinence and condom use requirements
- Can engage in vaginal intercourse with the participant, with and without condoms, as specified in protocol
- Protected from pregnancy by female surgical sterilization
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to easy genital tract sample collection
- Willing to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol
Who cannot join
- History of hysterectomy
- Surgical sterility or known history of infertility in male partner
- Sterility or known history of sperm dysfunction in male partner
- Currently pregnant by urine pregnancy test at the enrollment visit, or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome
- Current use of any hormonal contraceptive or a copper or hormonal IUD, or use of Depo-Provera in the last 120 days
- Currently breastfeeding or having breastfed an infant in the last two months, or planning to breastfeed during the course of the study
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- Significant gynecological abnormalities (including abnormal vaginal bleeding, excessive vaginal discharge, or vulvar/vaginal pain or irritation)
- Current UTI, vaginal candidiasis, or symptomatic bacterial vaginosis
- History of sensitivity/allergy to ZB-06 film components, for either the volunteer or her male partner
- In the last three months, either the volunteer or her male partner diagnosed with or treated for any STI or pelvic inflammatory disease, or either partner with known risk factors for sexually transmitted infections. Note: Women with a history of genital herpes or condylomata who have been asymptomatic for at least six months may be considered for eligibility
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis, or HIV at the screening visit
- Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for an STI
- Known current drug or alcohol abuse which could impact 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 either the volunteer or her male partner which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: An Exploratory Phase 1 Mechanism-of-action Study of ZB-06, a Vaginal Film Containing HC4-N, an Anti-sperm Monoclonal Antibody.
This is an early Phase 1 study to establish proof-of-concept by determining whether an intravaginal film containing a human contraceptive antibody (ZB-06) shows promise to provide contraceptive efficacy using the post-coital test, a surrogate measure of efficacy. The study will also evaluate the safety and pharmacokinetics of ZB-06.
- Conditions
- Contraception
- Being tested
- ZB-06
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZB-06Biological
ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
| Study group | Role | What they receive |
|---|---|---|
| ZB-06 | Experimental | All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse. Receives: Biological: ZB-06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surrogate Contraceptive Efficacy
Number of progressively motile sperm in aspirated endocervical mucus when using ZB-06 prior to intercourse.
Measured: 2-3 hours after sexual intercourse.
Secondary outcomes (1)
Adverse Events
Incidence of Grade 2 or Greater Adverse Events during product use versus during baseline observation.
Measured: Baseline through study exit encompassing a minimum of three menstrual cycles of 21-35 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start8 Feb 2021
- Primary completion25 Jan 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a Phase 1a, single center, open-label, crossover, mechanism of action and proof of concept study.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- KBio Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eastern Virginia Medical School
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04731818
- Sponsor's protocol ID
- ZB-06-01
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2021
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Thurman AR, Moench TR, Hoke M, Politch JA, Cabral H, Mausser E, Nador E, Morton J, Hamorsky K, Swope K, Bratcher B, Anderson DJ, Whaley KJ. ZB-06, a vaginal film containing an engineered human contraceptive antibody (HC4-N), demonstrates safety and efficacy in a phase 1 postcoital test and safety study. Am J Obstet Gynecol. 2023 Jun;228(6):716.e1-716.e12. doi: 10.1016/j.ajog.2023.02.024. Epub 2023 Mar 2.
PubMed 36870409
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase 1 Mechanism-of-action Study of ZB-06, a Vaginal Film Containing HC4-N, an Anti-sperm Monoclonal Antibody.
- ClinicalTrials.gov ID
- NCT04731818
- Acronym / sponsor ID
- ZB-06-01
- Conditions
- Contraception
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- KBio IncIndustry (pharma, biotech, devices)
- Collaborators
- Eastern Virginia Medical School
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 1 Feb 2021 (actual)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an early Phase 1 study to establish proof-of-concept by determining whether an intravaginal film containing a human contraceptive antibody (ZB-06) shows promise to provide contraceptive efficacy using the post-coital test, a surrogate measure of efficacy. The study will also evaluate the safety and pharmacokinetics of ZB-06.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a Phase 1a, single center, open-label, crossover, mechanism of action and proof of concept study.
| Arm | Type | Receives |
|---|---|---|
| ZB-06 | Experimental | Biological: ZB-06All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age 18 - 50 years, inclusive
- General good health, by volunteer history and per investigator judgment
- History of regular menstrual cycles of 21 - 35 days (inclusive), by volunteer report
- History of a normal PAP smear or ASCUS with negative HPV testing within the previous 12 months
- Willing to abstain from intercourse and use of vaginal medications, lubricants, and other products as required in the protocol
Key exclusion criteria (16 listed)
- History of hysterectomy
- Surgical sterility or known history of infertility in male partner
- Sterility or known history of sperm dysfunction in male partner
- Currently pregnant by urine pregnancy test at the enrollment visit, or within two calendar months from the last pregnancy outcome. Note: If recently pregnant must have had at least two spontaneous menses since pregnancy outcome
- Current use of any hormonal contraceptive or a copper or hormonal IUD, or use of Depo-Provera in the last 120 days
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 |
|---|---|---|
| ZB-06ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration. | Biological | ZB-06 |
Primary outcome
Surrogate Contraceptive Efficacy
Time frame: 2-3 hours after sexual intercourse.
Number of progressively motile sperm in aspirated endocervical mucus when using ZB-06 prior to intercourse.
1 secondary outcome
Adverse Events
Time frame: Baseline through study exit encompassing a minimum of three menstrual cycles of 21-35 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36870409Thurman AR, Moench TR, Hoke M, Politch JA, Cabral H, Mausser E, Nador E, Morton J, Hamorsky K, Swope K, Bratcher B, Anderson DJ, Whaley KJ. ZB-06, a vaginal film containing an engineered human contraceptive antibody (HC4-N), demonstrates safety and efficacy in a phase 1 postcoital test and safety study. Am J Obstet Gynecol. 2023 Jun;228(6):716.e1-716.e12. doi: 10.1016/j.ajog.2023.02.024. Epub 2023 Mar 2.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ZB-06 in people with Contraception, run by KBio 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 16 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: finished, as of the sponsor's last update on 15 Jan 2025. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surrogate Contraceptive Efficacy (time frame: 2-3 hours after sexual intercourse.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04731818, which also lists 1 linked publication.
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 15 Jan 2025.