A Randomized Phase 1 Study Comparing the PK, PD, Safety, and Immunogenicity of Proposed Biosimilar RGB‐14‐X and Denosumab in Healthy Adult Males

ABSTRACT Denosumab is a monoclonal antibody targeting the receptor activator of nuclear factor kappa‐b ligand widely used for the prevention of skeletal‐related events in patients with bone metastases. This Phase 1 randomized, double‐blind, two‐arm, parallel‐group study assessed the equivalence in p...

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Главные авторы:	Emmanuel Biver, Jean‐Jacques Body, Ashwin Sachdeva, Hana Študentová, Zsuzsanna Nagy, Attila Kun, Károly Horvát‐Karajz, Joachim Kiefer, Tímea Pap, Enikő Jókai, Ferenc Béla Vasas, Lothar Seefried
Формат:	Artigo
Язык:	Inglês
Опубликовано:	Wiley 2026-02-01
Серии:	Clinical and Translational Science
Предметы:	adverse events bioequivalence healthy subjects monoclonal antibodies pharmacodynamics pharmacokinetics‐pharmacodynamics
Online-ссылка:	https://doi.org/10.1111/cts.70468
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