NCT06469164

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: BioNTech SE · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed description

Part A will include single ascending dose levels and will assess the safety of BNT331 and describe the incidence of adverse events (AEs) for participants randomized at a ratio of 3:1 to BNT331 or placebo. Participants will receive one single dose of study treatment. Part B will include multiple ascending dose levels. Participants will be randomized at a ratio of 2:1 to BNT331 or placebo. Participants with BV will receive study treatment for five consecutive days. The vaginal inserts will be self-administered by the participant. The participants will receive detailed instructions from the investigator on how to self-administer the vaginal inserts at home.

Conditions

• Bacterial Vaginosis

Interventions

Type	Name	Description
DRUG	BNT331	Vaginal insert
OTHER	Placebo	Vaginal insert

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2024-06-21
• Last updated: 2025-08-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study