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

NCT06469164 | Completed Phase 1 FDA Drug

• 1 other identifier: BNT331-01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Bacterial Vaginosis

Keywords

Gardnerella spp.; Gardnerella vaginalis; BNT331

Outcome Measures

Primary Outcomes (4)

• Part A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 7 days post-dose

  In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.

  from first dose of study treatment up to 7 days post-dose

• Part B - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 120 days after the first dose

  In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.

  from first dose of study treatment up to 120 days after first dose

• Part A - Percentage of participants with serious adverse events (SAEs) with onset after first treatment dose and until 7 days post-dose

  In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.

  from first dose of study treatment up to 7 days post-dose

• Part B - Percentage of participants with SAEs with onset after first treatment dose and until 120 days after the first dose

  In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.

  from first dose of study treatment up to 120 days after first dose

Secondary Outcomes (7)

• Part A - Serum concentrations of BNT331 active substance at pre-specified timepoints

  from pre-dose up to 12 days post-dose

• Part B - Serum concentrations of BNT331 active substance at pre-specified timepoints

  from pre-dose up to 30 days after first dose

• Part A - Anti-drug antibody (ADA) prevalence and change of binding titers against BNT331 active substance in blood before study treatment and at 7 days post-dose

  from pre-dose up to 7 days post-dose

• Part B - ADA prevalence and change of binding titers against BNT331 active substance in blood before study treatment and at 6 days after the first dose, 21 to 30 days after the first dose, and 120 days after the first dose

  from pre-dose up to 120 days after first dose

• Part B - Number of participants with clinical cure

  At 6 days after first dose and 21 to 30 days after the first dose

Study Arms (5)

BNT331 - Part A

EXPERIMENTAL

Single ascending dose levels

Drug: BNT331

Placebo - Part A

PLACEBO COMPARATOR

Single dose

Other: Placebo

BNT331 - Part B Dose 1

EXPERIMENTAL

Fixed dose for 5 consecutive days

Drug: BNT331

BNT331 - Part B Dose 2

EXPERIMENTAL

Fixed dose for 5 consecutive days

Drug: BNT331

Placebo - Part B

PLACEBO COMPARATOR

Multiple dose

Other: Placebo

Interventions

BNT331 DRUG

Vaginal insert

BNT331 - Part A; BNT331 - Part B Dose 1; BNT331 - Part B Dose 2

Placebo OTHER

Vaginal insert

Placebo - Part A; Placebo - Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The participant must have been on the same form of highly effective contraception for at least 3 months prior to dosing (Visit 1) and must agree to keep this method until:
• Part A: 60 days after Follow-up Visit (Visit 3)
• Part B: at least 60 days after Test of Cure (ToC) Visit (Visit 3).
• Women of childbearing potential who agree not to donate or cryopreserve eggs (ova, oocytes) for the purposes of assisted reproduction during study:
• Part A: Within 3 months prior to dosing (Visit 1) and continuously until 60 days after Follow-up Visit (Visit 3)

You may not qualify if:

• 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.
• Has any history of an abnormal Pap smear which required cervical biopsy and/or cervical cauterization within 6 months of Visit 1.
• Malignancy within 5 years of screening, including but not limited to cervical carcinoma and carcinomas of the vagina and vulva.
• Has any condition including psychiatric illnesses that could interfere with their ability to understand or comply with the requirements of the study as determined by the investigator.
• Vulnerable individuals, i.e., are individuals whose willingness to participate in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. This includes all sponsor, study site, or third party (e.g., CRO, vendor) personnel directly involved in the conduct of the study and their family members or dependents, as well as all study site personnel otherwise supervised by the investigator.
• Part B only: Currently suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal disease symptoms including symptomatic VVC or infection with STI including Chlamydia trachomatis, Trichomonas vaginalis, or Neisseria gonorrhoeae.

Sponsors & Collaborators

• BioNTech SE: lead

Study Sites (6)

UAB Sexual Health Research Clinic

Birmingham, Alabama, 35294-0007, United States

Location

Praetorian Pharmaceutical Research, LLC

Marrero, Louisiana, 70072, United States

Location

Southern Clinical Research Associates - Metairie

Metairie, Louisiana, 70001, United States

Location

Women Under Study, LLC

New Orleans, Louisiana, 70125, United States

Location

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

Chattanooga Medical Research, LLC

Chattanooga, Tennessee, 37412, United States

Location

MeSH Terms

Conditions

Vaginosis, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• BioNTech Responsible Person

  BioNTech SE

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Observer-blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 21, 2024
• Study Start: July 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)