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Also known as BAT1806
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 developed by Biogen Inc. It is designed to target the IL-6 receptor (IL-6R). Biogen has studied it in a Phase 1 clinical trial in healthy male volunteers, comparing its pharmacokinetics, safety, and immunogenicity to Actemra when given subcutaneously.
BIIB800 targets the IL-6 receptor, also known as IL-6R, which is a receptor target. By binding to IL-6R, the small molecule is intended to interfere with interleukin-6 signaling. This mechanism is being explored in an investigational Phase 1 program rather than in an approved product.
Biogen Inc., which trades on Nasdaq under the ticker BIIB, is the developer of BIIB800. The company sponsored the Phase 1 study of the compound. Biogen is a biotechnology company focused on neuroscience and immunology programs, and BIIB800 is part of its investigational pipeline.
BIIB800 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. Biogen has completed one Phase 1 trial of the compound, and no active trials are currently listed for it. The completed study enrolled 300 participants.
BIIB800 has been studied in one Phase 1 trial, NCT06262477, titled a study to evaluate the pharmacokinetics, safety, and immunogenicity of BIIB800 subcutaneously compared to Actemra in healthy male participants. The trial was completed, enrolled 300 participants, was randomized and double blind, and took place in the United States and United Kingdom.