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A Randomized, Double-blinded, Single-dose, 3-arms Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2206 Injection vs Ustekinumab Injection (Stelara) in Healthy Chinese Male Subjects

Trial Profile

A Randomized, Double-blinded, Single-dose, 3-arms Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2206 Injection vs Ustekinumab Injection (Stelara) in Healthy Chinese Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 09 Dec 2022

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At a glance

  • Drugs Ustekinumab (Primary)
  • Indications Psoriasis
  • Focus Pharmacokinetics
  • Sponsors Bio-Thera Solutions

Most Recent Events

  • 22 Nov 2022 Primary endpoint has been met. (Pharmacokinetics Endpoint: Area under the plasma concentration versus time curve (AUC0-inf), as per published in the BioDrugs
  • 22 Nov 2022 Primary endpoint has been met. (Pharmacokinetics Endpoint: Peak plasma concentration (Cmax), as per published in the BioDrugs
  • 22 Nov 2022 Results evaluating the similarity of BAT2206 to its originator, ustekinumab, including pharmacokinetic profiles, immunogenicity, and safety in healthy Chinese male subjects, published in the BioDrugs

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