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A Phase 1 Bridging Study to Investigate and Compare the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Four Single Ascending Doses of Ropeginterferon Alfa-2b (P1101) in Healthy Japanese and Healthy Caucasian Subjects

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Trial Profile

A Phase 1 Bridging Study to Investigate and Compare the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Four Single Ascending Doses of Ropeginterferon Alfa-2b (P1101) in Healthy Japanese and Healthy Caucasian Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 04 Nov 2021

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At a glance

  • Drugs Ropeginterferon alfa-2b (Primary)
  • Indications Chronic myeloid leukaemia; Essential thrombocythaemia; Hepatitis B; Hepatitis C; Liver cancer; Myelofibrosis; Polycythaemia vera
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors PharmaEssentia Corporation

    • Most Recent Events

    • 16 Mar 2021 Results assessing pharmacokinetics, pharmacodynamics, safety, and tolerability of ropeginterferon alfa-2b in healthy Japanese subjects compared with Caucasian subjects, published in the Clinical Drug Investigation.
    • 22 Nov 2019 Status changed from recruiting to completed.
    • 11 Jun 2018 New trial record

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