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RECRUITING Phase 1

Phase 1 Study of Intravaginal KB15A

NCT07222020 · View on ClinicalTrials.gov ↗

Study Summary

The goal of this clinical trial is to determine the safety and mucosal pharmacokinetics of KB15A, a vaginal film containing an anti-sperm monoclonal antibody, in healthy adult women. Researchers will compare KB15A use to placebo use, primarily to see if KB15A is associated with adverse events, and also to understand the local and systemic distribution of the KB15A monoclonal antibody following use of the vaginal film. Participants will be assessed for the genital, mucosal and systemic safety and pharmacokinetics of KB15A in a preliminary single-dose phase of the study, where they will receive two single doses of either KB15A or placebo vaginal film, and again in a multiple-dose phase of the study, where they will receive 14 daily doses of either KB15A or placebo vaginal film.

Conditions Studied

Interventions

  • DRUG KB15A Vaginal Film
  • DRUG Placebo Vaginal Film

Study Locations (1)

Virginia

  • Virginia Health Sciences at Old Dominion University — Norfolk

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2026-01-01
Est. Completion 2026-12-28
Phase Phase 1

Sponsor

ZabBio

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07222020

The ClinicalTrials.gov registry entry for NCT07222020 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ZabBio, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Healthy Subjects appearing as the primary indexed condition, and to 2 interventions — of which KB15A Vaginal Film is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07222020 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT07222020 about?

NCT07222020 is a clinical study titled "Phase 1 Study of Intravaginal KB15A". The goal of this clinical trial is to determine the safety and mucosal pharmacokinetics of KB15A, a vaginal film containing an anti-sperm monoclonal antibody, in healthy adult women. Researchers will compare KB15A use to placebo use, primarily to see if KB15A is associated with adverse events, and a...

What is the current status of trial NCT07222020?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2026-01-01. Estimated completion is 2026-12-28.

What conditions does trial NCT07222020 study?

This clinical trial studies the following conditions: Healthy Subjects. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07222020?

The interventions under investigation include: KB15A Vaginal Film (DRUG), Placebo Vaginal Film (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07222020?

This trial is sponsored by ZabBio, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT07222020 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial