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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07133828 | A Study to Learn About the Safety of BIIB142 and How it is Processed in the Body of Healthy Adult Participants Aged 18 to 55 Years Old | PHASE1 | RECRUITING | 78 | — | — | Aug 29, 2025 | Aug 6, 2026 | May 6, 2026 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB142 Cohort 1A | EXPERIMENTAL | Participants will receive Dose A of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 2A | EXPERIMENTAL | Participants will receive Dose B of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 3A | EXPERIMENTAL | Participants will receive Dose C of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 4A | EXPERIMENTAL | Participants will receive Dose D of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 5A | EXPERIMENTAL | Participants will receive Dose E of BIIB142 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB142 Cohort 6A | EXPERIMENTAL | Participants will receive BIIB142 on Day 1 in the fasted followed by fed state in the first sequence, and vice versa in the second sequence. A washout period of 14 days will be maintained between both the sequences. Dose will be determined based on emerging PK data. |
| Part B [Multiple Ascending Dose (MAD)]: BIIB142 Cohort 1B | EXPERIMENTAL | Participants will receive Dose A of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part B (MAD): BIIB142 Cohort 2B | EXPERIMENTAL | Participants will receive Dose F of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part B (MAD): BIIB142 Cohort 3B | EXPERIMENTAL | Participants will receive Dose D of BIIB142 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Name | Type | Description |
|---|---|---|
| BIIB142 | DRUG | Administered Orally |
| BIIB142-Matching Placebo | DRUG | Administered Orally |
Key Inclusion Criteria: * Have a body mass index between 18 and 32 kilograms per square meter (kg/m\^2), inclusive, at screening. * Weight ≥ 50 kilograms (kg) at screening. * Negative polymerase chain reaction (PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in p...