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:Recruiting
Trial ID:
BNT331-01
NCT ID:
EudraCT ID:
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
Recruiting
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
Trial Drug
Phase
Phase 1
Type
Interventional
Estimated Enrolment
96
Estimated Trial Date
Jul 2024 - Jun 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
Recruiting
Location
Praetorian Pharmaceutical Research, LLC
Marrero, Louisiana, United States, 70072
Status
Recruiting
Location
Southern Clinical Research Associates - Metairie
Metairie, Louisiana, United States, 70001
Status
Recruiting
Location
Women Under Study, LLC
New Orleans, Louisiana, United States, 70125
Status
Recruiting
Location
Nucleus Network
Saint Paul, Minnesota, United States, 55114
Status
Active, not recruiting
Location
Velocity clinical Resesarch, Norfolk
Norfolk, Nebraska, United States, 68701
Status
Suspended