Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT06469164
PHASE1

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

Sponsor: BioNTech SE

View on ClinicalTrials.gov

Summary

This was 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).

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2024-07-01

Completion Date

2025-07-31

Last Updated

2026-10-05

Healthy Volunteers

Yes

Interventions

DRUG

BNT331

Vaginal insert

OTHER

Placebo

Vaginal insert

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