A randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of three formulations of adalimumab (M923, US Sourced Humira and EU Sourced Humira) in healthy subjects

Trial Profile

A randomized, double-blind, three-arm, parallel group, single-dose study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of three formulations of adalimumab (M923, US Sourced Humira and EU Sourced Humira) in healthy subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 16 Nov 2016

At a glance

  • Drugs Adalimumab (Primary)
  • Indications Autoimmune disorders; Inflammation
  • Focus Pharmacokinetics
  • Sponsors Baxter Innovations GmbH
  • Most Recent Events

    • 08 Jun 2016 According to a Momenta media release, key data from this trial will be presented at the European League Against Rheumatism Annual Congress (EULAR) 2016 Annual Meeting.
    • 18 Aug 2015 Status changed from recruiting to completed as per ISRCTN: Current Controlled Trials record.
    • 04 Aug 2015 According to a Momenta Pharmaceuticals media release, the target date for the first regulatory submission for approval is 2017.
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