A Randomised, Double-Blind, Parallel-Group, Single-Dose trial to determine pharmacokinetic equivalence in healthy subjects

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 04 Mar 2025

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04 Mar 2025 New trial record
15 Oct 2024 According to Results presented at the 32nd United European Gastroenterology Week, this study provides the basis for the marketing authorisation of the proposed ustekinumab biosimilar FYB202, together with an extensive analytical characterisation and the results of an efficacy and safety trial in patients with moderate-to-severe plaque psoriasis.
15 Oct 2024 Primary endpoint has been met (pharmacokinetic parameters of ustekinumab) , according to Results presented at the 32nd United European Gastroenterology Week

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