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

NCT04731818 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: ZB-06-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events

  Baseline through study exit encompassing a minimum of three menstrual cycles of 21-35 days.

Study Arms (1)

ZB-06

EXPERIMENTAL

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

Biological: ZB-06

Interventions

ZB-06 BIOLOGICAL

ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.

ZB-06

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The study will enroll 15 couples comprised of women in monogamous heterosexual relationships with male partners.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KBio Inc: lead
• Eastern Virginia Medical School: collaborator

Study Sites (1)

Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

Related Publications (1)

• 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.

  PMID: 36870409 DERIVED

Results Point of Contact

• Title: Andrea Thurman MD, Principal Investigator
• Organization: Eastern Virginia Medical School

thurmaar@evms.edu

7574465808

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1a, single center, open-label, crossover, mechanism of action and proof of concept study.

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 1, 2021
• Study Start: February 8, 2021
• Primary Completion: January 25, 2022
• Study Completion: February 24, 2022
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2025-01

Locations

US (1)