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BIIB145 · 1 trial · 1 indication
| 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...
BIIB145 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a trial evaluating its safety and how it is processed in the body of healthy adult participants. It is not approved for any indication.
BIIB145 targets BTK, a protein involved in cellular signaling. As a small molecule, it is designed to interact with this target. However, its specific mechanism of action and therapeutic potential are still under investigation in early-stage clinical trials.
BIIB145 is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and pharmacokinetics in healthy volunteers.
BIIB145 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the safety and processing of BIIB145 in the body.
BIIB145 is being studied in one Phase 1 clinical trial, identified as NCT07225517. This randomized, double-blind, controlled study is recruiting 104 healthy adult participants in the United States to evaluate the safety and how BIIB145 is processed in the body.
No alternative names for BIIB145 have been disclosed. It is identified solely by its development code, BIIB145, in the context of its ongoing clinical trial and development by Biogen Inc.