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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04737876 | A Study to Evaluate the Safety, Tolerability, and Fecal Pharmacokinetics of BX002-A in Healthy Adults | PHASE1 | COMPLETED | 18 | — | — | Oct 28, 2020 | Dec 21, 2020 | Jan 25, 2022 | 1 | United States |
Evaluated by reviewing adverse events
| Arm | Type | Description |
|---|---|---|
| BX002-A | EXPERIMENTAL | BX002-A: 1 mL liquid for multiple dose oral administration |
| Placebo | PLACEBO_COMPARATOR | Placebo: 1 mL liquid for multiple dose oral administration |
| Name | Type | Description |
|---|---|---|
| BX002-A | BIOLOGICAL | bacteriophage cocktail |
| Placebo | OTHER | Placebo |
Inclusion Criteria: 1. Healthy adults 18-65 years old 2. Able to understand study procedures and sign informed consent Exclusion Criteria: 1. Evidence or history of clinically significant underlying conditions 2. Women who are pregnant or nursing, or plan to become pregnant during study, or women...