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The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety

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Trial Profile

The Study of Infliximab (CMAB008 and Remicade) in Healthy Subjects to Compare the PK and Safety

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Jan 2023

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At a glance

  • Drugs Infliximab biobetter (Primary) ; Infliximab
  • Indications Ankylosing spondylitis; Crohn's disease; Psoriasis; Rheumatoid arthritis; Ulcerative colitis
  • Focus Pharmacokinetics
  • Sponsors Taizhou Mabtech Pharmaceuticals

    • Most Recent Events

    • 06 Jan 2023 Results assessing the pharmacokinetic characteristics of CMAB008 and Remicade in healthy subjects and patients with moderately to severely active rheumatoid arthritis (RA) were investigated using a population modeling approach, and the pharmacokinetic similarity of CMAB008 to Remicade from NCT04779892, NCT03478111trials, published in the Advances in Therapy.
    • 01 Sep 2022 Primary endpoint has been met. (Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 1680 Hours After the Single Infusion of CMAB008/Remicade), as per Results published in the Clinical Pharmacology in Drug Development
    • 01 Sep 2022 Results published in the Clinical Pharmacology in Drug Development

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