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A Randomized, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (ENZ215, EU-sourced Prolia, and US-sourced Prolia) in Healthy Adult Male Volunteers

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Trial Profile

A Randomized, Double-blind, Three-arm, Parallel-group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (ENZ215, EU-sourced Prolia, and US-sourced Prolia) in Healthy Adult Male Volunteers

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 13 Jul 2023

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At a glance

  • Drugs Denosumab (Primary)
  • Indications Postmenopausal osteoporosis
  • Focus Pharmacokinetics
  • Sponsors Enzene Biosciences

Most Recent Events

  • 12 Jul 2023 Primary endpoint (Area under the drug concentration-time curve from time 0 to infinity (AUC0-inf) of ENZ215 and EU- and US-sourced Prolia) has been met, according to a Fresenius Kabi media release.
  • 12 Jul 2023 Primary endpoint (Area under the drug concentration-time curve from day 0 to day 270 (AUC0-t) of ENZ215 and EU- and US-sourced Prolia) has been met, according to a Fresenius Kabi media release.
  • 12 Jul 2023 Primary endpoint (Maximum observed drug concentration (Cmax) of ENZ215 and EU- and US-sourced Prolia) has been met, according to a Fresenius Kabi media release.

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