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NCT06469164 · ClinicalTrials.gov registry record · Phase 1
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 1 study, sponsored by BioNTech SE.
- Completed
- Registry status
- Phase 1
- Development phase
- 102
- Enrollment target
NCT06469164: Completed Phase 1 study, sponsored by BioNTech SE.
NCT06469164 is a Phase 1 study that has completed, run by BioNTech SE. The registered enrollment target is 102 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06469164, a Phase 1 study, has completed, sponsored by BioNTech SE.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 102 participants
- Enrollment target
Study 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).
Primary Outcome
In participants who have received at least one dose of BNT331 or placebo. For each dose level cohort of BNT331 and for the combined placebo group.
Interventions
- OTHER Placebo
- DRUG BNT331
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2025-07-31 |
| Phase | Phase 1 |
What the finished NCT06469164 record still lists
NCT06469164 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06469164 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06469164 about?
NCT06469164 is a clinical study titled "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". 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).
What is the current status of trial NCT06469164?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 102 participants. The study started on 2024-07-01. Estimated completion is 2025-07-31.
What interventions are being tested in trial NCT06469164?
The interventions under investigation include: Placebo (OTHER), BNT331 (DRUG).
Who is sponsoring clinical trial NCT06469164?
This trial is sponsored by BioNTech SE, which has 53 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06469164's enrollment target sits among peer trials
102 543rd of 2000 higher than 1,455 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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