# 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

> **NCT06469164** · PHASE1 · COMPLETED · sponsor: **BioNTech SE** · enrollment: 102 (actual)

## Conditions studied

- Bacterial Vaginosis

## Interventions

- **DRUG:** BNT331
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT06469164
- **Lead sponsor:** BioNTech SE
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2024-07-01
- **Primary completion:** 2025-07-31
- **Final completion:** 2025-07-31
- **Target enrollment:** 102 (ACTUAL)
- **Last updated:** 2025-08-07


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06469164

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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". Retrieved via AI Analytics 2026-07-09 from https://api.ai-analytics.org/clinical/NCT06469164. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*