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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04444050 | Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants | PHASE1 | COMPLETED | 48 | — | — | Jun 23, 2020 | May 19, 2021 | Oct 20, 2022 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| Part 1 Single Ascending Dose (SAD): Panel 1 | EXPERIMENTAL | - |
| Part 1 SAD: Panel 2 | EXPERIMENTAL | - |
| Part 1 SAD: Panel 3 | EXPERIMENTAL | - |
| Part 1 SAD: Panel 4 | EXPERIMENTAL | - |
| Part 1 SAD: Panel 5 | EXPERIMENTAL | - |
| Part 1 SAD: Panel 6 | EXPERIMENTAL | - |
| Part 1 SAD: Optional Split-dose Panel | EXPERIMENTAL | - |
| Part 2 Multiple Ascending Dose (MAD): Panel 1 | EXPERIMENTAL | - |
| Part 2 MAD: Panel 2 | EXPERIMENTAL | - |
| Part 2 MAD: Panel 3 | EXPERIMENTAL | - |
| Part 2 MAD: Panel 4 | EXPERIMENTAL | - |
| Part 2 MAD: Optional (to be determined) Panel | EXPERIMENTAL | - |
| Part 3 MAD in Japanese Participants (J-MAD): Panel 1 | EXPERIMENTAL | - |
| Part 3 J-MAD: Panel 2 | EXPERIMENTAL | - |
| Part 3 J-MAD: Panel 3 | EXPERIMENTAL | - |
| Part 3 J-MAD: Optional (to be determined) Panel | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BMS-986331 | DRUG | Specified dose on specified days |
| Placebo, Matching BMS-986331 | OTHER | Specified dose on specified days |
Inclusion Criteria: * No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations * A body mass index of 18 - 32 kg/m2, inclusive * Women and men must agree to follow specific methods of contraception, if applicable For J...