A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT06262477
- Run by
- Biogen
- People needed
- 300
- Starts
- 2024-01-02
- Expected to finish
- 2024-10-04
- Last updated by the study team
- 2025-10-06
Who can join
Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.
Where it is running
- Fortrea Clinical Research Unit Inc. — Daytona Beach, Florida, United States
- Fortrea Clinical Research Unit Inc. — Dallas, Texas, United States
- Fortrea Clinical Research Unit Inc. — Madison, Wisconsin, United States
- Fortrea Clinical Research Unit Inc. — Leeds, West Yorkshire, United Kingdom
Full record on ClinicalTrials.gov
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