drugset / Trial / NCT06262477
A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of the study is to show equivalence in pharmacokinetics (PK) of BIIB800 and Actemra following SC administration of a single dose to healthy male participants. The secondary objective of the study is to evaluate PK over time, clinical safety, pharmacodynamic (PD) profiles and immunogenicity of BIIB800 and Actemra.
Timeline
- Start
- 2024-01-02
- Primary completion
- 2024-09-25
- Completion
- 2024-10-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BAT1806 | Unknown | — | Subcutaneous |
| Subject | Tocilizumab | Monoclonal antibody | — | Subcutaneous |
Indications
No indication recorded.