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
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
102actual
Sites
6
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-07-01 | actual | When the study began enrolling |
| Primary completion | 2025-07-31 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-31 | actual | The whole study's end, after follow-up |
| First posted | 2024-06-21 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Bacterial Vaginosis
Interventions
- Drug: BNT331
- Other: Placebo
Primary outcomes
what the primary-completion date above is the date OFPart A - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 7 days post-dose
measured from first dose of study treatment up to 7 days post-dose
Part B - Percentage of participants with adverse events (AEs) with onset after first treatment dose and until 120 days after the first dose
measured from first dose of study treatment up to 120 days after first dose
Part A - Percentage of participants with serious adverse events (SAEs) with onset after first treatment dose and until 7 days post-dose
measured from first dose of study treatment up to 7 days post-dose
Part B - Percentage of participants with SAEs with onset after first treatment dose and until 120 days after the first dose
measured from first dose of study treatment up to 120 days after first dose
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