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A Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or Autoinjector

Trial Profile

A Randomized, Parallel-Group, Open-Label Study to Estimate the Relative Bioavailability, Tolerability and Safety of a Single Dose of Belimumab Administered Subcutaneously to Healthy Subjects by Prefilled Syringe or Autoinjector

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 03 Sep 2023

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At a glance

  • Drugs Belimumab (Primary)
  • Indications Systemic lupus erythematosus
  • Focus Pharmacokinetics
  • Sponsors GlaxoSmithKline; GSK
  • Most Recent Events

    • 13 Jun 2015 Primary endpoint has been met. (Plasma PK assessment for Cmax, AUC(0-t), AUC(0-inf)), according to an abstract 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.
    • 22 May 2014 According to the ClinicalTrials.gov record, status changed from active, no longer recruiting to completed.
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