A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of M834 (Abatacept Biosimilar Candidate), US-Sourced Orencia®, and European Union (EU)-Sourced Orencia® in Normal Healthy Volunteers

Trial Profile

A Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Safety, and Immunogenicity of M834 (Abatacept Biosimilar Candidate), US-Sourced Orencia®, and European Union (EU)-Sourced Orencia® in Normal Healthy Volunteers

Completed
Phase of Trial: Phase I

Latest Information Update: 01 Nov 2017

At a glance

  • Drugs Abatacept (Primary)
  • Indications Autoimmune disorders; Inflammation
  • Focus Pharmacokinetics
  • Sponsors Momenta Pharmaceuticals
  • Most Recent Events

    • 01 Nov 2017 According to a Momenta Pharmaceuticals media release, M834 did not meet its primary pharmacokinetic (PK) endpoints in this trial.
    • 20 Oct 2017 Status changed from active, no longer recruiting to completed.
    • 19 May 2017 Planned End Date changed from 1 Jun 2017 to 1 Jul 2017.
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