Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE1 | COMPLETED | 102 | — | — | Jul 1, 2024 | Jul 31, 2025 | Aug 7, 2025 | 6 | United States |
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| BNT331 - Part A | EXPERIMENTAL | Single ascending dose levels |
| Placebo - Part A | PLACEBO_COMPARATOR | Single dose |
| BNT331 - Part B Dose 1 | EXPERIMENTAL | Fixed dose for 5 consecutive days |
| BNT331 - Part B Dose 2 | EXPERIMENTAL | Fixed dose for 5 consecutive days |
| Placebo - Part B | PLACEBO_COMPARATOR | Multiple dose |
| Name | Type | Description |
|---|---|---|
| BNT331 | DRUG | Vaginal insert |
| Placebo | OTHER | Vaginal insert |
Inclusion Criteria (applicable to all participants unless otherwise specified): * Have given written informed consent by signing and dating the informed consent form (ICF) before initiation of any study-specific procedures. * Participant reported assigned female sex at birth, at least 18 years of a...