A Phase I, Randomized, Double-Blind, Parallel-Group, Single-Dose Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of MSB11022, US-Reference Product, and EU-Reference Medicinal Product (Humira®) in Healthy Subjects

Trial Profile

A Phase I, Randomized, Double-Blind, Parallel-Group, Single-Dose Trial to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity of MSB11022, US-Reference Product, and EU-Reference Medicinal Product (Humira®) in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 21 Feb 2017

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Ankylosing spondylitis; Crohn's disease; Plaque psoriasis; Psoriatic arthritis; Rheumatoid arthritis; Ulcerative colitis
  • Focus Pharmacokinetics
  • Most Recent Events

    • 20 Jun 2016 New trial record
    • 10 Jun 2016 Primary endpoint has been met. (AUC from time 0 to the last quantifiable concentration (AUC(0-last))), as per results published in the British Journal of Clinical Pharmacology.
    • 10 Jun 2016 Primary endpoint has been met. (Maximum observed concentration Cmax), as per results published in the British Journal of Clinical Pharmacology.
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