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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 to evaluate its safety and how it is processed in the body. The drug is not approved for any condition and is being tested in a research setting.
BIIB145 targets BTK, a protein involved in cellular signaling. By targeting BTK, the drug may modulate certain biological pathways, though its full mechanism and potential therapeutic applications are still under investigation in early-stage clinical trials.
BIIB145 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting a Phase 1 clinical trial to assess the drug's safety and pharmacokinetics in healthy adult participants.
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 study the drug's safety and how it is processed in the body.
BIIB145 is being studied in a Phase 1 clinical trial registered as NCT07225517. This randomized, double-blind, controlled study is recruiting 104 healthy adult participants in the United States to evaluate the safety and processing of BIIB145 in the body.