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A Randomized, Double-blind, Single-dose, Parallel Three-arm Comparative Study on Pharmacokinetics and Safety of BAT2506 Injection Versus the EU-licensed and US-licensed Simponi in Healthy Chinese Male Subjects

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Trial Profile

A Randomized, Double-blind, Single-dose, Parallel Three-arm Comparative Study on Pharmacokinetics and Safety of BAT2506 Injection Versus the EU-licensed and US-licensed Simponi in Healthy Chinese Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 30 Aug 2023

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At a glance

  • Drugs Golimumab (Primary)
  • Indications Psoriatic arthritis
  • Focus Pharmacokinetics
  • Sponsors Bio-Thera Solutions

Most Recent Events

  • 25 Aug 2023 Status changed from recruiting to completed.
  • 11 Jan 2023 Planned End Date changed from 31 Dec 2023 to 31 Oct 2023.
  • 11 Jan 2023 Planned primary completion date changed from 31 Dec 2023 to 30 Jun 2023.

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