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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07225517 | A Study to Learn More About the Safety of BIIB145 and How it is Processed in the Body of Healthy Adult Participants | PHASE1 | RECRUITING | 104 | — | — | Dec 18, 2025 | Feb 2, 2027 | Feb 6, 2026 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| Part A [Single Ascending Dose (SAD)]: BIIB145 Cohort 1A | EXPERIMENTAL | Participants will receive Dose A of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 2A | EXPERIMENTAL | Participants will receive Dose B of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 3A | EXPERIMENTAL | Participants will receive Dose C of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 4A | EXPERIMENTAL | Participants will receive Dose D of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 5A | EXPERIMENTAL | Participants will receive Dose E of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 6A | EXPERIMENTAL | Participants will receive Dose F of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part A (SAD): BIIB145 Cohort 7A | EXPERIMENTAL | Participants will receive Dose G of BIIB145 or a matching placebo on Day 1 in a fasted state. |
| Part B [Food Effect]: BIIB145 Cohort 1B | EXPERIMENTAL | Participants will receive BIIB145 on Day 1 in the fasted state, followed by the fed state in the first sequence, and vice versa in the second sequence. A washout period of 7 days will be maintained between the two sequences. Dose will be determined based on safety and PK data of SAD Cohort 6A as well as safety, PK and pharmacodynamics (PD) data from previous cohorts. |
| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 1C | EXPERIMENTAL | Participants will receive Dose B of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 2C | EXPERIMENTAL | Participants will receive Dose C of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 3C | EXPERIMENTAL | Participants will receive Dose H of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Part C [Multiple Ascending Dose (MAD)]: BIIB145 Cohort 4C | EXPERIMENTAL | Participants will receive Dose F of BIIB145 or a matching placebo administered orally once daily for 14 days in a fasted state. |
| Name | Type | Description |
|---|---|---|
| BIIB145 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
Key Inclusion Criteria: * Have a body mass index (BMI) between 18 and 32 kilograms per square metre (kg/m\^2), inclusive, and a total body weight \> 50 kilograms (kg) at Screening and Check-In. * Must be in good health as determined by the Investigator, based on medical history and Screening evalua...