Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® 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 BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 270 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 45mg/0.5ml BAT2206 Injection or Stelara® (EU-licensed and US-licensed).

Timeline

Start

2020-08-08

Primary completion

2021-04-19

Completion

2021-04-19

Publications

• Wu M, Li X, Yang D, Wang M, Zhang H, Li C, Mai J, Yang L, Qi Y, Yu JC, Yang X, Wang Z, Gu C, Ding Y. Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial. BioDrugs. 2023 Jan;37(1):89-98. doi: 10.1007/s40259-022-00563-5. Epub 2022 Nov 22.

Drugs

Indications