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A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade and US Sourced Remicade) in Healthy Subjects

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Trial Profile

A Randomised, Single-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of Infliximab (SB2, EU Sourced Remicade and US Sourced Remicade) in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Feb 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; Registrational
  • Sponsors Samsung Bioepis
  • Most Recent Events

    • 01 Nov 2017 Results assessing PK profiles of SB2 in healthy subjects and patients with rheumatoid arthritis using patient data from NCT01936181 and NCT01922336 trials presented at the 25th United European Gastroenterology Week
    • 30 May 2016 According to a Biogen media release, The European Commission (EC) has granted marketing authorization in the European Union (EU) for FLIXABI (Infliximab Biosimilar) based on the data from this and a phase III trial (see profile 235251).
    • 23 May 2016 According to Merck media release, Biologics License Application (BLA) of SB2 (infliximab) by Samsung Bioepis has been accepted for review by the U.S. Food and Drug Administration (FDA).
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