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A Multicenter, Randomized, Open-Label, Parallel Group Phase 1 Pharmacokinetic Comparability Study of Benralizumab Administrated Using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers

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Trial Profile

A Multicenter, Randomized, Open-Label, Parallel Group Phase 1 Pharmacokinetic Comparability Study of Benralizumab Administrated Using Accessorized Pre-Filled Syringe (APFS) or Autoinjector (AI) in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Sep 2021

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At a glance

  • Drugs Benralizumab (Primary)
  • Indications Asthma; Chronic obstructive pulmonary disease
  • Focus Pharmacokinetics
  • Acronyms AMES
  • Sponsors AstraZeneca

    • Most Recent Events

    • 04 Oct 2019 Results presented in an AstraZeneca media release.
    • 04 Oct 2019 According to an AstraZeneca media release, the US Food and Drug Administration (FDA) has approved the self administration of FASENRA (benralizumab) in a pre-filled, single use auto-injector.This approval is supported by data from Phase III GRECO and Phase I AMES trials.
    • 25 Feb 2019 Results presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology

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