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Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Doses of NNC0365-3769 (Mim8) in Healthy Subjects and in Subjects With Haemophilia A With or Without Factor VIII Inhibitors

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Trial Profile

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Doses of NNC0365-3769 (Mim8) in Healthy Subjects and in Subjects With Haemophilia A With or Without Factor VIII Inhibitors

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 10 Oct 2024

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At a glance

  • Drugs Mim 8 (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; First in man; Proof of concept
  • Acronyms FRONTIER1
  • Sponsors Novo Nordisk

    • Most Recent Events

    • 22 Dec 2023 Results assessing the safety, PK, pharmacodynamics (PD), and exploratory efficacy of Mim8 in participants with hemophilia A, with or without FVIII inhibitors, published in the Journal of Thrombosis and Haemostasis.
    • 05 Nov 2023 Status changed from active, no longer recruiting to completed.
    • 13 Dec 2022 Results 5 cohorts (n=42) of the MAD part of the study presented at the 64th American Society of Hematology Annual Meeting and Exposition

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