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First-In-Human, Randomized, Double-Blinded, Placebo-Controlled Trial in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of ARGX-117 Co-mixed With rHuPH20

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Trial Profile

First-In-Human, Randomized, Double-Blinded, Placebo-Controlled Trial in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of ARGX-117 Co-mixed With rHuPH20

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Sep 2022

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At a glance

  • Drugs Empasiprubart (Primary) ; Empasiprubart (Primary) ; Hyaluronidase
  • Indications Autoimmune disorders; Autoimmune haemolytic anaemia; COVID 2019 infections; Transplant rejection
  • Focus Adverse reactions; First in man
  • Sponsors argenx

Most Recent Events

  • 20 Sep 2022 Status changed from active, no longer recruiting to completed.
  • 07 Feb 2022 Status changed from recruiting to active, no longer recruiting.
  • 05 Nov 2021 Planned number of patients changed from 104 to 112.

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