Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB037 · 1 trial · 1 indication
Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG), and brain MRI findings (including the occurrence of vasogenic edema and incident hemorrhage).
| Arm | Type | Description |
|---|---|---|
| BIIB037 | EXPERIMENTAL | A single dose of BIIB037 by intravenous infusion. |
| Placebo | PLACEBO_COMPARATOR | A single dose of placebo matching BIIB037 by intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| BIIB037 | DRUG | Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg. |
| Placebo | OTHER | Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion. |
Key Inclusion Criteria: * Must be ambulatory * Must have a clinical diagnosis of Alzheimer's Disease (AD) consistent with the following: 1. Probable Alzheimer's Disease (AD), according to National Institute of Neurological and Communicative Disease and Stroke and Alzheimer's Disease and Related ...
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BIIB037 is an investigational small molecule being developed for the treatment of Alzheimer's Disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with Alzheimer's Disease to evaluate its safety and tolerability.
BIIB037 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. Biogen is conducting clinical trials to evaluate the safety and efficacy of BIIB037 in patients with Alzheimer's Disease.
BIIB037 is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug remains under investigation for the treatment of Alzheimer's Disease.
BIIB037 has one completed Phase 1 clinical trial registered as NCT01397539, titled 'Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease.' The trial enrolled 53 participants in the United States and was a randomized, double-blind, placebo-controlled study.
BIIB037 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Alzheimer's Disease. The completed Phase 1 trial evaluated safety and tolerability, but the drug has not yet progressed to later-stage trials or received marketing approval.