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A Randomized, Open-Label, 2-Part, 2-Arm, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Comparability of Pharmacokinetics of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device or an Auto-Injector

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A Randomized, Open-Label, 2-Part, 2-Arm, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Comparability of Pharmacokinetics of Etrolizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device or an Auto-Injector

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Apr 2021

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At a glance

  • Drugs Etrolizumab (Primary)
  • Indications Crohn's disease; Ulcerative colitis
  • Focus Pharmacokinetics; Registrational
  • Sponsors Genentech

    • Most Recent Events

    • 29 Mar 2021 Results assessing pharmacokinetics comparability, tolerability, and safety of etrolizumab administered by prefilled syringe with needle safety device (PFS-NSD) in healthy volunteers, published in the Advances in Therapy.
    • 17 Mar 2021 Results presented at the 122nd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
    • 13 Apr 2018 Status changed from active, no longer recruiting to completed.

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