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drugset / Trial / NCT04711343

Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects

NCT04711343 ↗

Phase 1 Completed 216 enrolled Bio-Thera Solutions
RandomizedParallel-groupQuadruple-blindTreatment

Summary

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2306 Injection vs Cosentyx® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 216 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 150mg BAT2306 Injection or Cosentyx® (EU-licensed and US-licensed).

Timeline

Start
2022-06-08
Primary completion
2023-05-03
Completion
2023-06-05

Drugs

EvaluationDrugModalityDoseRoute
Subject BAT2306 Monoclonal antibody 150 mg Subcutaneous
Comparator Secukinumab Monoclonal antibody 150 mg Subcutaneous

Indications

psoriasis