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Phase 1, Randomized Open Label, Multiple Dose, Parallel Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of The Proposed Pegfilgrastim Biosimilar (PF-06881894) And Us-approved Neulasta (Registered) In Healthy Volunteers

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Trial Profile

Phase 1, Randomized Open Label, Multiple Dose, Parallel Study To Assess The Immunogenicity Of Multiple Subcutaneous (SC) Doses Of The Proposed Pegfilgrastim Biosimilar (PF-06881894) And Us-approved Neulasta (Registered) In Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 23 Jun 2020

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Febrile neutropenia; Neutropenia
  • Focus Therapeutic Use
  • Sponsors Pfizer
  • Most Recent Events

    • 10 Jun 2020 Results evaluating the pharmacodynamic/pharmacokinetic (PD/PK) equivalence, immunogenicity, and safety of PF-06881894 vs pegfilgrastim reference products (US- and EU-Neulasta) in healthy volunteers published in the Advances in Therapy
    • 15 Aug 2018 Status changed from recruiting to completed.
    • 03 Jul 2018 Planned End Date changed from 29 Jul 2018 to 25 Jul 2018.
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