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A Randomized, Double-blind, Single-dose, Parallel-group Design, 2 Arm Study Comparing the Pharmacokinetic, Pharmacodynamic, Safety, Tolerability, and Immunogenicity Profiles of AVT03 and Prolia® in Healthy Male Subjects

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Trial Profile

A Randomized, Double-blind, Single-dose, Parallel-group Design, 2 Arm Study Comparing the Pharmacokinetic, Pharmacodynamic, Safety, Tolerability, and Immunogenicity Profiles of AVT03 and Prolia® in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 31 May 2024

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Osteoporosis
  • Focus Pharmacokinetics
  • Sponsors Alvotech

    • Most Recent Events

    • 05 Apr 2024 Status changed from active, no longer recruiting to completed.
    • 29 Jan 2024 Results presented in an Alvotech Media Release.
    • 18 Oct 2023 Planned End Date changed from 17 Oct 2023 to 20 Dec 2023.

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