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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

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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: 25 Jun 2025

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At a glance

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

Most Recent Events

  • 20 Jun 2025 According to Bio-Thera Solutions media release, company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for USYMRO (ustekinumab). This positive CHMP opinion on USYMRO was based on the totality of evidence comprising a comprehensive analytical, non-clinical and clinical data package.
  • 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

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