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

January 14, 2025 updated by: KBio Inc

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Eastern Virginia Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ZB-06
All participants will receive a single ZB-06 film for intravaginal administration prior to intercourse.
Biological: ZB-06
ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2-3 hours after sexual intercourse.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 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.
Baseline through study exit encompassing a minimum of three menstrual cycles of 21-35 days.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Antibodies
Time Frame: Baseline, 2-3 hours & 24 hours & 1-month post-intercourse, with and without product use.
Concentration of ZB-06 human contraceptive antibody in vaginal fluid, endocervical mucus, and serum.
Baseline, 2-3 hours & 24 hours & 1-month post-intercourse, with and without product use.
Agglutination Titers
Time Frame: Baseline, 2-3 hours & 24 hours & 1-month post-intercourse, with and without product use.
Sperm agglutination titer of ZB-06 human contraceptive antibody in vaginal fluid, endocervical mucus, and serum by endpoint dilution.
Baseline, 2-3 hours & 24 hours & 1-month post-intercourse, with and without product use.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KBio Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eastern Virginia Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZB-06-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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