Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta in Healthy Subjects

Trial Profile

Multiple-doses, Randomised, Double-blind, Three-periods, Two-sequences Crossover Study to Assess the Immunogenicity and Pharmacodynamic Comparability of a Biosimilar Pegfilgrastim (B12019) and the Reference Product Neulasta in Healthy Subjects

Completed
Phase of Trial: Phase I

Latest Information Update: 04 Oct 2017

At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Neutropenia
  • Focus Pharmacodynamics
  • Sponsors Cinfa Biotech
  • Most Recent Events

    • 04 Oct 2017 According to a Cinfa Biotech media release, based on the data from this and other study (see profile 265690), the European Medicines Agency (EMA) has accepted Marketing Authorisation Application (MAA) for B12019 to treat chemotherapy-induced neutropenia.
    • 12 Sep 2017 Primary endpoint (Absolute Neutrophil count (ANC)) has been met, according to results presented at the 42nd European Society for Medical Oncology Congress.
    • 12 Sep 2017 Results of this and other study (NCT02629562), presented at the 42nd European Society for Medical Oncology Congress.
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