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
Public ClinicalTrials.gov record NCT06469164. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT06469164
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- BioNTech SE
- Industry
- Enrollment
- 102 participants
Conditions and interventions
Conditions
Interventions
- BNT331 Drug
- Placebo Other
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2024
- Primary completion
- Jul 30, 2025
- Completion
- Jul 30, 2025
- Last update posted
- Aug 6, 2025
2024 – 2025
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Sexual Health Research Clinic | Birmingham | Alabama | 35294-0007 | — |
| Praetorian Pharmaceutical Research, LLC | Marrero | Louisiana | 70072 | — |
| Southern Clinical Research Associates - Metairie | Metairie | Louisiana | 70001 | — |
| Women Under Study, LLC | New Orleans | Louisiana | 70125 | — |
| Nucleus Network | Saint Paul | Minnesota | 55114 | — |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37412 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06469164, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2025 · Synced May 17, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06469164 live on ClinicalTrials.gov.