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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: 11 Dec 2025

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At a glance

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

Most Recent Events

  • 24 Nov 2025 According to an Alvotech media release, results of this study demonstrate equivalent pharmacokinetics and efficacy, and comparable safety and immunogenicity to the reference product and were reported in peer reviewed publications
  • 24 Nov 2025 According to an Alvotech media release, based on a totality of evidence that included comparative analytical, pharmacokinetic and pharmacodynamic data, and data from NCT05126784 and NCT05395091 European Commission (EC) has approved AVT03 as a biosimilar to Prolia and Xgeva (denosumab) in 2 formulations- 60 mg/mL single use pre-filled syringe for the treatment of osteoporosis and bone loss; and 70 mg/mL single use vial to prevent skeletal events in adults with advanced malignancies.
  • 10 Oct 2024 Results published in an Alvotech Media Release.

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