Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Aducanumab · 4 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Aducanumab IV | ACTIVE_COMPARATOR | Participants will receive a single weight-based dose of aducanumab via IV infusion on Day 1. |
| Aducanumab SC | EXPERIMENTAL | Participants will receive 2 fixed doses of aducanumab via SC injection on Days 1 and 15. |
| Aducanumab Intravenous | EXPERIMENTAL | Participants will receive aducanumab as body weight-based dose, via IV infusion for approximately 1 hour on Day 1. |
| Aducanumab Subcutaneous | EXPERIMENTAL | Participants will receive aducanumab as fixed dose, via SC injection on Day 1. |
| Cohort 1 | EXPERIMENTAL | IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo |
| Cohort 2 | EXPERIMENTAL | IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo |
| Cohort 3 | EXPERIMENTAL | IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo |
| Cohort 4 | EXPERIMENTAL | IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo |
| Name | Type | Description |
|---|---|---|
| Aducanumab | BIOLOGICAL | Administered as specified in the treatment arm. |
| Placebo | DRUG | IV administration of 0.9% sodium chloride |
Key Inclusion Criteria: * Have a body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive * Japanese participant has both biological parents and all 4 grandparents of Japanese descent * Have a negative polymerase chain reaction test result for severe acute respiratory syndr...
Aducanumab is an investigational monoclonal antibody being studied for Alzheimer's Disease. It is also used in clinical trials involving healthy volunteers to assess its pharmacokinetics and bioavailability. The drug is developed by Biogen Inc. and has received FDA accelerated approval designation.
Aducanumab is developed by Biogen Inc., a biopharmaceutical company traded on NASDAQ under the ticker BIIB. The drug is being studied in clinical trials for Alzheimer's Disease and in healthy volunteer studies.
Aducanumab is in Phase 1 clinical development. It has completed two Phase 1 trials with a total enrollment of 123 participants. The drug has received FDA accelerated approval designation, but it remains investigational and is not yet approved for commercial use.
Aducanumab has completed several Phase 1 trials, including NCT02434718 in Japanese participants with Alzheimer's Disease, NCT02782975 and NCT04924140 assessing bioavailability in healthy participants, and NCT05216887 comparing subcutaneous and intravenous dosing in healthy volunteers.
Aducanumab is a monoclonal antibody designed to target amyloid beta, a protein implicated in Alzheimer's Disease pathology. By binding to amyloid beta, it aims to reduce the accumulation of plaques in the brain, which is a hallmark of the disease.