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

PHASE1CompletedINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

July 1, 2024

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2025

Conditions
Bacterial Vaginosis
Interventions
DRUG

BNT331

Vaginal insert

OTHER

Placebo

Vaginal insert

Trial Locations (6)

37412

Chattanooga Medical Research, LLC, Chattanooga

55114

Nucleus Network, Saint Paul

70001

Southern Clinical Research Associates - Metairie, Metairie

70072

Praetorian Pharmaceutical Research, LLC, Marrero

70125

Women Under Study, LLC, New Orleans

35294-0007

UAB Sexual Health Research Clinic, Birmingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

BioNTech SE

INDUSTRY