Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BIIB800 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| BIIB800 | EXPERIMENTAL | Participants will receive a single dose of BIIB800 via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study. |
| Actemra | EXPERIMENTAL | Participants will receive a single dose of Actemra via autoinjector, administered SC in the outer area of the upper arm on Day 1 of the study. |
| Name | Type | Description |
|---|---|---|
| BIIB800 | DRUG | Administered as specified in the treatment arm. |
| Actemra | DRUG | Administered as specified in the treatment arm. |
Key Inclusion Criteria: * Have a body mass index between 18.5 and 29.9 kilograms per meter square (kg/m\^2), inclusive. * Total body weight between 60.0 and 90.0 kg, inclusive. * Systolic blood pressure \<135 millimeters of mercury (mmHg) or \>85 mmHg at Screening, after being supine for at least 5...
BIIB800 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its pharmacokinetics, safety, and immunogenicity when given subcutaneously compared to Actemra in healthy male participants.
BIIB800 is being developed by Biogen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical research on this investigational small molecule in healthy volunteer populations.
BIIB800 is in Phase 1 clinical development. One Phase 1 trial has been completed, which enrolled 300 healthy male participants. The drug is investigational and has not been approved by regulatory authorities.
BIIB800 has one completed clinical trial registered as NCT06262477. This Phase 1 study evaluated the pharmacokinetics, safety, and immunogenicity of BIIB800 administered subcutaneously compared to Actemra in healthy male participants. The trial was conducted in the United States and United Kingdom.
BIIB800 is not the same as Actemra. In clinical trials, BIIB800 is being compared to Actemra as an active control. The study evaluates how BIIB800 performs relative to Actemra in terms of pharmacokinetics, safety, and immunogenicity when both are given subcutaneously.