A Study to Evaluate the Pharmacokinetics, Safety and Immunogenicity of BIIB800 Subcutaneously (SC) Compared to Actemra® in Healthy Male Participants - Trial NCT06262477
Access comprehensive clinical trial information for NCT06262477 through Pure Global AI's free database. This Phase 1 trial is sponsored by Biogen and is currently Recruiting. The study focuses on Healthy Volunteer. Target enrollment is 300 participants.
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Study Focus
Sponsor & Location
Biogen
Timeline & Enrollment
Phase 1
Jan 02, 2024
Nov 30, 2024
Primary Outcome
Maximum Serum Concentration (Cmax) of Tocilizumab,Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Tocilizumab,Area Under the Concentration-Time Curve up to the Last Measurable Concentration (AUC0-t) of Tocilizumab
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06262477
Non-Device Trial