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

Early Phase 1

Completed

Conditions: Contraception

Interventions: Biological: ZB-06

Registration Number: NCT04731818

Lead Sponsor: KBio Inc

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZB-06	ZB-06	All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.