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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 is a Phase 1 study that has completed, run by BioNTech SE. The registered enrollment target is 102 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06469164
The ClinicalTrials.gov registry entry for NCT06469164 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioNTech SE, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06469164 reports 0 study locations.
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.
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