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A Randomized, Double-Blind, Single-Dose, 3-Arm, Parallel Group Study to Determine the Pharmacokinetic Similarity of ABP 959 and Eculizumab (Soliris Registered Trademark) in Healthy Male Subjects

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Trial Profile

A Randomized, Double-Blind, Single-Dose, 3-Arm, Parallel Group Study to Determine the Pharmacokinetic Similarity of ABP 959 and Eculizumab (Soliris Registered Trademark) in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Aug 2022

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At a glance

  • Drugs Eculizumab (Primary)
  • Indications Haematological disorders
  • Focus Pharmacodynamics; Pharmacokinetics
  • Sponsors Amgen

    • Most Recent Events

    • 17 Jun 2022 Results supporting the previously demonstrated pharmacokinetic-pharmacodynamic similarity of ABP 959 with eculizumab reference product by providing additional data on similarity in pharmacokinetic exposure with respect to unbound eculizumab reference product and 50% total hemolytic complement activity (CH50), presented at the 27th Congress of the European Haematology Association.
    • 06 Nov 2019 Results assessing the relationship between PK parameters and ADAs for ABP 959 and eculizumab RP released at the 61st Annual Meeting and Exposition of the American Society of Hematology
    • 08 Jul 2017 Status changed from recruiting to completed.

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