Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects

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.

Timeline

Start

2018-06-13

Primary completion

2019-07-17

Completion

2019-07-17

Publications

• Ebbers HC, Taylor PC, Leng X, Wei W, Kinsella NM, Zhou Y, Yang X, Chamberlain P. A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product. Rheumatol Ther. 2025 Jun;12(3):529-546. doi: 10.1007/s40744-025-00760-y. Epub 2025 Apr 8.
• Zhang H, Wang H, Wei H, Chen H, Liu J, Li C, Zhu X, Li X, Yu J, Zhou Y, Yang X, Wang Z, Wu M, Ding Y. A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men. Front Pharmacol. 2021 Jan 25;11:609522. doi: 10.3389/fphar.2020.609522. eCollection 2020.

Drugs

Indications