Contraception
Conditions
Brief 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. The study will also evaluate the safety and pharmacokinetics of ZB-06.
Interventions
BIOLOGICALZB-06
ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
Sponsors
Eastern Virginia Medical School
KBio Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a Phase 1a, single center, open-label, crossover, mechanism of action and proof of concept study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surrogate Contraceptive Efficacy | 2-3 hours after sexual intercourse. | Number of progressively motile sperm in aspirated endocervical mucus when using ZB-06 prior to intercourse. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Baseline through study exit encompassing a minimum of three menstrual cycles of 21-35 days. | Incidence of Grade 2 or Greater Adverse Events during product use versus during baseline observation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ZB-06 All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.
ZB-06: ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | ZB-06 |
|---|---|
| Age, Continuous | 39.8 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 5 Participants |
| Region of Enrollment United States | 8 participants |
| Sex/Gender, Customized Female | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Surrogate Contraceptive Efficacy
Number of progressively motile sperm in aspirated endocervical mucus when using ZB-06 prior to intercourse.
Time frame: 2-3 hours after sexual intercourse.
Population: Data from all participants who complete both the baseline and the product use post coital test visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ZB-06 | Surrogate Contraceptive Efficacy | Baseline Post Coital Test | 25.86 sperm per high power field | Standard Deviation 30.58 |
| ZB-06 | Surrogate Contraceptive Efficacy | Product Use Post Coital Test | 0.04 sperm per high power field | Standard Deviation 0.06 |
| ZB-06 | Surrogate Contraceptive Efficacy | Post Product Use Post Coital Test | 47.39 sperm per high power field | Standard Deviation 37.43 |
p-value: <0.0001ANOVA
Secondary
Adverse Events
Incidence of Grade 2 or Greater Adverse Events during product use versus during baseline observation.
Time frame: Baseline through study exit encompassing a minimum of three menstrual cycles of 21-35 days.
Population: Assess the incidence of Grade 2 or greater adverse events (AEs) in the participant and/or her male partner in the interval between baseline visit 4 and visit 6.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| ZB-06 | Adverse Events | Product use | 1 Number of TEAEs |
| ZB-06 | Adverse Events | Post Product Use | 0 Number of TEAEs |