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A Phase 1, Randomized, Open-label, Parallel-group Trial to Investigate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Different Single Subcutaneous Dose Levels of Efgartigimod Co-administered With rHuPH20 in Healthy Adult Male Subjects

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A Phase 1, Randomized, Open-label, Parallel-group Trial to Investigate the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Different Single Subcutaneous Dose Levels of Efgartigimod Co-administered With rHuPH20 in Healthy Adult Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 01 Feb 2022

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At a glance

  • Drugs Efgartigimod alfa (Primary) ; Hyaluronidase
  • Indications Autoimmune disorders; Bullous pemphigoid; Chronic inflammatory demyelinating polyradiculoneuropathy; Idiopathic thrombocytopenic purpura; Myasthenia gravis; Myositis; Pemphigus
  • Focus Pharmacodynamics
  • Sponsors argenx

    • Most Recent Events

    • 14 Dec 2021 Results of comparison of pharmacokinetic pharmacodynamic simulations data from this study (Subcutaneous administration) to other studies (intravenous administration) for selection of subcutaneous dose of efgartigimod for phase III study presented at the 63rd American Society of Hematology Annual Meeting and Exposition
    • 27 Dec 2019 Status changed from recruiting to completed.
    • 23 Jul 2019 New trial record

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