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Phase I to study pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta

Trial Profile

Phase I to study pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta

Completed
Phase of Trial: Phase I

Latest Information Update: 05 Aug 2018

At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Febrile neutropenia
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics
  • Most Recent Events

    • 05 Aug 2018 Results published in the British Journal of Clinical Pharmacology.
    • 12 Dec 2017 New trial record
    • 09 Dec 2017 Primary endpoint (Determine PK similarity) has been met, according to results presented at the 40th Annual San Antonio Breast Cancer Symposium.
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