Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects
Status:
Unknown status
Trial end date:
2019-03-31
Target enrollment:
Participant gender:
Summary
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.