A Randomized, Parallel-Group, Open-Label Study to Evaluate the Absolute Bioavailability, Pharmacokinetics, Tolerability and Safety of a High Concentration Formulation of Belimumab (HGS1006), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Healthy Subjects

Trial Profile

A Randomized, Parallel-Group, Open-Label Study to Evaluate the Absolute Bioavailability, Pharmacokinetics, Tolerability and Safety of a High Concentration Formulation of Belimumab (HGS1006), a Fully Human Monoclonal Anti-BLyS Antibody, Administered Subcutaneously to Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 08 Sep 2017

At a glance

  • Drugs Belimumab (Primary) ; Belimumab (Primary)
  • Indications Anti-neutrophil cytoplasmic antibody-associated vasculitis; Lupus nephritis; Membranous glomerulonephritis; Myasthenia gravis; Myositis; Renal transplant rejection; Sjogren's syndrome; Systemic lupus erythematosus; Systemic scleroderma
  • Focus Pharmacokinetics
  • Sponsors Human Genome Sciences
  • Most Recent Events

    • 08 Sep 2017 Results of pooled analysis assessing pharmacokinetics and pharmacodynamics of BEL114448, BEL116119, BEL112341 published in the Clinical Pharmacokinetics.
    • 30 Jan 2013 Trial association changed from Human Genome Sciences to GlaxoSmithKline, as Human Genome Sciences acquired by GlaxoSmithKline.
    • 14 Nov 2012 Results presented at the 76th Annual Scientific Meeting of the American College of Rheumatology and the 47th Annual Meeting of the Association of Rheumatology Health Professionals.
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