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A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects

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Trial Profile

A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Dec 2023

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At a glance

  • Drugs Tocilizumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Pharmacokinetics
  • Sponsors Celltrion

Most Recent Events

  • 03 Jun 2023 Primary endpoint has been met (AUC from time zero to the last quantifiable concentration (AUC0-last)) , according to Results presented at the 24th Annual Congress of the European League Against Rheumatism
  • 03 Jun 2023 Primary endpoint has been met (Serum concentration-time curve (AUC) from time zero to infinity (AUC0-inf)), according to Results presented at the 24th Annual Congress of the European League Against Rheumatism
  • 03 Jun 2023 Primary endpoint has been met (Maximum serum concentration (Cmax)) , according to Results presented at the 24th Annual Congress of the European League Against Rheumatism

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