A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects.
biosimilar
denosumab
immunogenicity
inter-subject variability
pharmacodynamics
pharmacokinetics
Journal
Frontiers in pharmacology
ISSN: 1663-9812
Titre abrégé: Front Pharmacol
Pays: Switzerland
ID NLM: 101548923
Informations de publication
Date de publication:
2020
2020
Historique:
received:
06
04
2020
accepted:
10
08
2020
entrez:
2
11
2020
pubmed:
3
11
2020
medline:
3
11
2020
Statut:
epublish
Résumé
This study was conducted to explore the tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese subjects. This is a randomized, double-blind, two-arm, parallel study performed to examine the bioequivalence of denosumab biosimilar, QL1206, with that of Xgeva Similar PK properties as those of Xgeva Similar PK and PD characteristics were exhibited by QL1206 as compared to those of Xgeva
Identifiants
pubmed: 33132906
doi: 10.3389/fphar.2020.01329
pmc: PMC7580200
doi:
Types de publication
Journal Article
Langues
eng
Pagination
01329Informations de copyright
Copyright © 2020 Zhang, Wu, Zhu, Li, Li, Sun, Liu, Liu, Wei, Niu and Ding.
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