Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06262477 | A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants | PHASE1 | COMPLETED | 300 | — | — | Jan 2, 2024 | Oct 4, 2024 | Oct 6, 2025 | 4 | United States, United Kingdom |
| 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...