A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects

A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects

ObjectiveThis study was conducted to explore the tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese subjects.MethodsThis is a randomized, double-blind, two-arm, parallel study performed to examine the bioequivalence of denosum...

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Bibliographic Details
Main Authors: Hong Zhang, Min Wu, Xiaoxue Zhu, Cuiyun Li, Xiaojiao Li, Jixuan Sun, Chengjiao Liu, Quan Liu, Wei Wei, Junqi Niu, Yanhua Ding
Format: Article
Language:English
Published: Frontiers Media S.A. 2020-10-01
Series:Frontiers in Pharmacology
Subjects:
denosumab
biosimilar
immunogenicity
pharmacokinetics
pharmacodynamics
inter-subject variability
Online Access:https://www.frontiersin.org/article/10.3389/fphar.2020.01329/full

Internet

https://www.frontiersin.org/article/10.3389/fphar.2020.01329/full

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