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A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis | Clinical Trials | Clareo Health

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A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis

A Phase I Randomized, Double-blind, Placebo-controlled, Safety, Tolerability, and Pharmacokinetic Trial of BNT331 Administered in Single Ascending Doses in Healthy Women and Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis

NCT06469164•BioNTech SE

View on ClinicalTrials.gov

Summary

This is a two-part, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy (for Part B) of BNT331 in healthy women (Part A) and in women diagnosed with bacterial vaginosis (BV) (Part B).

Detailed Description

Part A will include single ascending dose levels and will assess the safety of BNT331 and describe the incidence of adverse events (AEs) for participants randomized at a ratio of 3:1 to BNT331 or placebo. Participants will receive one single dose of study treatment. Part B will include multiple ascending dose levels. Participants will be randomized at a ratio of 2:1 to BNT331 or placebo. Participants with BV will receive study treatment for five consecutive days. The vaginal inserts will be self-administered by the participant. The participants will receive detailed instructions from the investigator on how to self-administer the vaginal inserts at home.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Have given written informed consent by signing and dating the informed consent form (ICF) before initiation of any study-specific procedures.
•Participant reported assigned female sex at birth, at least 18 years of age and pre-menopausal, as determined by the investigator.
•Not menstruating or having vaginal bleeding:
•* Part A and Part B: At Visit 0 and not expecting to menstruate during Visit 1 and until Visit 3.
•* Part B only: At Visit 0 and Visit 1 and do not expect to menstruate within the next 6 days after Visit 1, until the Early Response Visit (Visit 2).
•Part A only: Are healthy according to screening procedures. Part B only: Participants suffering from BV but who are otherwise healthy in the clinical judgement of the investigator.
•* Note: Participants with pre-existing stable disease (e.g., obesity, hypertension, etc.), defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 90 days before Visit 0, can be included.
•Part A only: Should not have any clinical signs of BV as assessed by the absence of all Amsel's criteria and a normal Nugent score at screening, or other vaginal symptoms, including symptomatic vulvo-vaginal candidiasis (VVC) or infection with sexually transmitted infection (STI) pathogens including Chlamydia trachomatis, Trichomonas vaginalis, or Neisseria gonorrhoeae.
•Able to participate in the study as an outpatient, to attend all required visits, and to comply with all study requirements.
•Women of childbearing potential must have a negative highly sensitive urine pregnancy test result prior to study treatment initiation.
+18 more criteria

Exclusion Criteria

•Pregnant, lactating, or planning to become pregnant during their study participation and for at least:
•* Part A: 60 days after Follow-up Visit (Visit 3)
•* Part B: 60 days after ToC Visit (Visit 3).
•Have genital lesions, including active herpes simplex virus or syphilitic lesions, or other vaginal or vulvar conditions.
•Part A only: Have active STI.
•Had received antifungal or antimicrobial therapy (in Part A, systemic or topical; in Part B, systemic or vaginal) within 14 days prior to the Visit 1.
•Are using a Copper intrauterine device, or any vaginal hormonal products (including NuvaRing®) as a form of contraception.
•Had a history of drug or alcohol abuse within the past 12 months, as determined by the investigator.
•Had participated in any investigational study within 30 days before the Visit 1 or is currently participating or plans to participate in any investigational, or observational study.
•Has any history of allergies, hypersensitivities, or intolerance to the study treatments including any excipients thereof.
+5 more criteria

Locations (6)

UAB Sexual Health Research Clinic

Birmingham, Alabama, United States

Praetorian Pharmaceutical Research, LLC

Marrero, Louisiana, United States

Southern Clinical Research Associates - Metairie

Metairie, Louisiana, United States

Women Under Study, LLC

New Orleans, Louisiana, United States

Nucleus Network

Saint Paul, Minnesota, United States

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, United States

Key Dates

Start Date

July 1, 2024

Primary Completion Date

July 31, 2025

Completion Date

July 31, 2025

Last Updated

August 7, 2025

Enrollment

102

ACTUAL participants

Conditions

Bacterial Vaginosis

Interventions

BNT331

DRUG

Placebo

OTHER

An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis

NCT07394777

Bacterial Vaginosis (BV)

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ENROLLING_BY_INVITATION

Vaginal Ecosystem and Network in the United States Study

NCT06472765

Bacterial VaginosisCandidiasis+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A First-in-human Safety Trial of BNT331 Administered as Single Ascending Doses in Healthy Women and as Multiple Ascending Doses in Women Diagnosed With Bacterial Vaginosis

Inclusion Criteria

Exclusion Criteria

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