An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film

Study Overview
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Brief Summary
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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.

Official Title
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An Exploratory Phase 1 Mechanism-of-action Study of ZB-06, a Vaginal Film Containing HC4-N, an Anti-sperm Monoclonal Antibody.

Conditions
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Contraception

Intervention / Treatment
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* Biological: ZB-06


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: This is a Phase 1a, single center, open-label, crossover, mechanism of action and proof of concept study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZB-06<br>All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse. | Biological: ZB-06<br>* ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surrogate Contraceptive Efficacy | Number of progressively motile sperm in aspirated endocervical mucus when using ZB-06 prior to intercourse. | 2-3 hours after sexual intercourse. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Incidence of Grade 2 or Greater Adverse Events during product use versus during baseline observation. | Baseline through study exit encompassing a minimum of three menstrual cycles of 21-35 days. |