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A Phase 1, Randomized, Open-label, Single-dose, Two-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of the Pre-filled Syringe and Auto-injector of CT-P13 in Healthy Subjects

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Trial Profile

A Phase 1, Randomized, Open-label, Single-dose, Two-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of the Pre-filled Syringe and Auto-injector of CT-P13 in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Dec 2019

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At a glance

  • Drugs Infliximab (Primary)
  • Indications Ankylosing spondylitis; Crohn's disease; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors Celltrion

Most Recent Events

  • 08 Mar 2019 According Celltrion media release, the initial data of this study was presented at the 14th congress of European Crohns and Colitis Organisation (ECCO) show that the subcutaneous (SC) formulation of CT-P13 is comparable in terms of efficacy and safety with the intravenous (IV) formulation of CT-P13 for the treatment of patients with moderate to severe Crohns Disease (CD) up to week 54.
  • 08 Mar 2019 Results published in the Celltrion Media Release
  • 16 Oct 2018 Status changed from active, no longer recruiting to completed.

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