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Single Center, Randomized, Double-blind, 3-Period, 3-Treatments, 3-Way Crossover Pharmacokinetics (PK)/Pharmacodynamics (PD) Trial to Assess PK, PD,Safety and Tolerability of MYL-1401H After Single Subcutaneous Injection at One Dose Level (2 mg) Comparing to an EU and US Marketed Drug Product (Neulasta) in Healthy Volunteers

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Single Center, Randomized, Double-blind, 3-Period, 3-Treatments, 3-Way Crossover Pharmacokinetics (PK)/Pharmacodynamics (PD) Trial to Assess PK, PD,Safety and Tolerability of MYL-1401H After Single Subcutaneous Injection at One Dose Level (2 mg) Comparing to an EU and US Marketed Drug Product (Neulasta) in Healthy Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 18 Jul 2018

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At a glance

  • Drugs Pegfilgrastim (Primary)
  • Indications Autoimmune disorders; Cancer; Febrile neutropenia
  • Focus First in man; Pharmacodynamics; Pharmacokinetics
  • Sponsors Mylan

    • Most Recent Events

    • 01 Jun 2018 Results published in the Journal of Cancer Research and Clinical Oncology
    • 12 Dec 2017 Results assessing the immunogenicity of MYL-1401H across three studies (MYL-1401H-1001, MYL-1401H-1002 and MYL-1401H-3001) presented at the 59th Annual Meeting and Exposition of the American Society of Hematology
    • 11 Oct 2016 Primary endpoint (Maximum Serum Concentration (Cmax) of pegfilgrastim) has been met.

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