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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 drug being developed by Biogen Inc. It is currently in Phase 1 clinical development. The specific diseases or conditions it is intended to treat have not been disclosed, and its only listed trial to date enrolls healthy adult volunteers rather than patients.
BIIB145 targets BTK, a protein also known as Bruton's tyrosine kinase. BTK is an enzyme involved in signaling pathways in certain immune and blood cells, which is why BTK-directed drugs are studied across a range of conditions. BIIB145 is a small molecule designed to interact with this protein target.
BIIB145 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is the sponsor of the clinical program for this investigational small molecule. No partner or co-development arrangement for BIIB145 is disclosed in the available program information.
BIIB145 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The program currently has one Phase 1 trial, which is actively recruiting participants, and no completed trials.
BIIB145 is being studied in one Phase 1 trial, NCT07225517, titled a study to learn more about the safety of BIIB145 and how it is processed in the body of healthy adult participants. The trial is recruiting, is randomized, double-blind, and controlled, and plans to enroll 104 healthy volunteers in the United States.
The Phase 1 trial of BIIB145, NCT07225517, enrolls healthy adult volunteers age 18 years and older, with no restriction by sex. It is a randomized, double-blind, controlled study of 104 participants conducted in the United States. The trial is currently recruiting and has not yet been completed.