A Randomized, Single-blind, Single-dose, 3-arm, Parallel Group Study to Determine the Pharmacokinetic Similarity of ABP 710 and Infliximab (Remicade 'Registered Trademark') in Healthy Adult Subjects

Trial Profile

A Randomized, Single-blind, Single-dose, 3-arm, Parallel Group Study to Determine the Pharmacokinetic Similarity of ABP 710 and Infliximab (Remicade 'Registered Trademark') in Healthy Adult Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Nov 2017

At a glance

  • Drugs Infliximab (Primary)
  • Indications Inflammation; Rheumatic disorders
  • Focus Pharmacokinetics
  • Sponsors Amgen
  • Most Recent Events

    • 01 Nov 2017 Primary endpoint has been met. (The primary objective of this study is to determine the PK similarity (as assessed principally by AUCinf) of ABP 710 following a 5 mg/kg intravenous (IV) infusion relative to that of a 5 mg/kg IV infusion ofinfliximab (US) or a 5 mg/kg IV infusion of infliximab (EU)) as per results presented at the 25th United European Gastroenterology Week
    • 01 Nov 2017 Results presented at the 25th United European Gastroenterology Week
    • 17 Jun 2017 Results comparing pharmacokinetics of ABP-710 and infliximab sourced from the European Union (n=98), presented at the 18th Annual Congress of the European League Against Rheumatism
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