A single-centre, double-blind, parallel, randomised phase I trial investigating the bioequivalence of BOW 015 (infliximab biosimilar) to Remicade in healthy male volunteers

Trial Profile

A single-centre, double-blind, parallel, randomised phase I trial investigating the bioequivalence of BOW 015 (infliximab biosimilar) to Remicade in healthy male volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Apr 2016

At a glance

  • Drugs Infliximab (Primary)
  • Indications Autoimmune disorders
  • Focus First in man; Pharmacokinetics
  • Sponsors EPIRUS Biopharmaceuticals
  • Most Recent Events

    • 13 Jun 2015 Pooled safety data from this trial and a phase 3 trial in active rheumatoid arthritis patients presented at the 16th Annual Congress of the European League Against Rheumatism.
    • 13 Jun 2015 Results presented at the 16th Annual Congress of the European League Against Rheumatism.
    • 10 Jun 2015 Results presented at the European League Against Rheumatism Annual Congress (EULAR 2015), as reported by EPIRUS media release.
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