Trial Profile

A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia, and US Sourced Prolia) in Healthy Male Subjects

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 21 Nov 2024

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At a glance

15 Nov 2024 According to the Samsung BioLogics Media Release, announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two denosumab biosimilars based on clinical data from this study.
15 Oct 2023 Primary endpoint (Cmax) has been met, according to a Samsung Bioepis media release.
15 Oct 2023 Primary endpoint (AUClast) has been met, according to a Samsung Bioepis media release.

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