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A Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra in Healthy Chinese Male Subjects

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Trial Profile

A Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra in Healthy Chinese Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Jun 2024

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Juvenile rheumatoid arthritis; Rheumatoid arthritis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Bio-Thera Solutions

    • Most Recent Events

    • 24 Jun 2024 According to a Biogen media release, based on results from NCT06262477 and NCT03606876, the European Commission (EC) has granted approval for TOFIDENCETM, a biosimilar monoclonal antibody referencing ROACTEMRA. The intravenous formulation of TOFIDENCE has been granted marketing authorization by the EC for the treatment of moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19.
    • 05 Jun 2023 Primary endpoint (Pharmacokinetics Endpoint) has been met, according to a Dr Reddys Laboratories.
    • 16 Nov 2021 Status changed from active, no longer recruiting to completed.

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