A Study Comparing Pharmacokinetics, Safety, Tolerability And Immunogenicity Of FKB327 A Biosimilar Of Adalimumab With European Union (EU)-Approved Humira And United States (US)- Licensed Humira After Single Subcutaneous Doses In Healthy Subjects.

Trial Profile

A Study Comparing Pharmacokinetics, Safety, Tolerability And Immunogenicity Of FKB327 A Biosimilar Of Adalimumab With European Union (EU)-Approved Humira And United States (US)- Licensed Humira After Single Subcutaneous Doses In Healthy Subjects.

Completed
Phase of Trial: Phase I

Latest Information Update: 08 Feb 2017

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions; First in man; Pharmacokinetics
  • Most Recent Events

    • 08 Feb 2017 New trial record
    • 30 Jan 2017 Primary endpoint (Equivalence analysis of the geometric means of AUC0-t , AUC0-infinity and Cmax for FKB327, EU-Humira and US-Humira, and that EU-Humira and US-Humira) has been met, according results to published in the British Journal of Clinical Pharmacology.
    • 30 Jan 2017 Results published in the British Journal of Clinical Pharmacology.
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