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

Trial status:Study Complete
Trial ID:
BNT331-01
NCT ID:
NCT06469164
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Study Complete

Trial Details

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).

Medical Condition
  • Bacterial Vaginosis
    • Trial Drug
  • BNT331
    • Phase
    Phase 1
    Type
    Interventional
    Estimated Enrolment
    102
    Estimated Trial Date
    Jul 2024 - Jul 2025

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Female
    Healthy Volunteers
    Yes

    Trial Locations

    Location
    Status
    Location
    UAB Sexual Health Research Clinic
    Birmingham, Alabama, United States, 35294-0007
    Status
    Location
    Praetorian Pharmaceutical Research, LLC
    Marrero, Louisiana, United States, 70072
    Status
    Location
    Southern Clinical Research Associates - Metairie
    Metairie, Louisiana, United States, 70001
    Status
    Location
    Women Under Study, LLC
    New Orleans, Louisiana, United States, 70125
    Status
    Location
    Nucleus Network
    Saint Paul, Minnesota, United States, 55114
    Status
    Location
    Chattanooga Medical Research, LLC
    Chattanooga, Tennessee, United States, 37412
    Status