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An open label, randomised, three arm, single dose, multicentre, parallel group study in healthy subjects to compare the pharmacokinetics of subcutaneous mepolizumab when delivered as a liquid drug product in a safety syringe or an auto injector with a reconstituted lyophilised drug product from a vial

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Trial Profile

An open label, randomised, three arm, single dose, multicentre, parallel group study in healthy subjects to compare the pharmacokinetics of subcutaneous mepolizumab when delivered as a liquid drug product in a safety syringe or an auto injector with a reconstituted lyophilised drug product from a vial

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2023

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At a glance

  • Drugs Mepolizumab (Primary)
  • Indications Asthma
  • Focus Pharmacokinetics; Registrational
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK

Most Recent Events

  • 04 Jun 2019 According to a GlaxoSmithKline media release, data from this trial supported the positive opinion of CHMP recommending two new methods for administering Nucala (mepolizumab) to patients with severe eosinophilic asthma: a pre-filled pen and a pre-filled safety syringe, to be taken once every four weeks.
  • 28 Mar 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
  • 25 Aug 2017 Status changed from active, no longer recruiting to completed.

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