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).
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Ustekinumab, thus to evaluate the 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
270
45mg/0.5 ml; single dose;prefilled syringe; subcutaneous injection
45mg/0.5 ml; single dose;prefilled syringe; subcutaneous injection
45mg/0.5 ml; single dose;prefilled syringe; subcutaneous injection
The First Hospital of Jilin University
Jilin City, China
Pharmacokinetics Endpoint: Peak plasma concentration (Cmax)
Time frame: 0-4months
Pharmacokinetics Endpoint: Area under the plasma concentration versus time curve (AUC0-inf)
Time frame: 0-4months
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