It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT1806 Injection vs Actemra® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 138 subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed). The study has a screening period of 7 days. PK blood samples will be collected from subjects to determine the serum concentration of tocilizumab, thus to evaluate the change and similarity of the pharmacokinetics of the three study drugs. The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
138
Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Pharmacokinetics Endpoint
AUC0-inf
Time frame: 0-2months
Pharmacokinetics Endpoint
AUC0-t
Time frame: 0-2months
Pharmacokinetics Endpoint
Cmax
Time frame: 0-2months
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