A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males.
Anhye KimJang-Hee HongWonsuk ShinHyounggyoon YooJin Gyu JungJean-Yves ReginsterSungHyun KimYunJu BaeJeeHye SuhSera KimEunKyung LeeStuart L SilvermanPublished in: Expert opinion on biological therapy (2024)
ClinicalTrials.gov: NCT06037395.
Keyphrases
- double blind
- bone mineral density
- placebo controlled
- giant cell
- postmenopausal women
- clinical trial
- open label
- computed tomography
- image quality
- contrast enhanced
- body composition
- dual energy
- phase iii
- phase ii
- study protocol
- positron emission tomography
- magnetic resonance imaging
- magnetic resonance
- randomized controlled trial