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A Randomized, Double-blind, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva in Healthy Male Subjects

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Trial Profile

A Randomized, Double-blind, Parallel Design, Single Dose, 2-arm Study Comparing the Pharmacokinetic, Safety and Immunogenicity Profiles of AVT03 and US-Xgeva in Healthy Male Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 May 2025

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At a glance

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

Most Recent Events

  • 18 Mar 2025 According to an Alvotech media release, the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia (denosumab) and Xgeva (denosumab).
  • 02 Jul 2024 Primary endpoint has been met. (Co-primary PK endpoint_AUC0-t: area under the serum concentration-time curve up to time t, where t is the last time point with a concentration above the lower limit of quantitation), according to an Alvotech media release.
  • 02 Jul 2024 Primary endpoint has been met. (Co-primary PK endpoint_Cmax: maximum serum concentration), according to an Alvotech media release.

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