{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["11"],"submitter":["Zhang H"],"pubmed_abstract":["<h4>Objective</h4>This study was conducted to explore the tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese subjects.<h4>Methods</h4>This is a randomized, double-blind, two-arm, parallel study performed to examine the bioequivalence of denosumab biosimilar, QL1206, with that of Xgeva<sup>®</sup> (Denosumab) as a reference drug. A single dose of 120 mg/kg of the denosumab biosimilar or Xgeva<sup>®</sup> was administered to the subjects, who were followed up for 134 days.<h4>Results</h4>Similar PK properties as those of Xgeva<sup>®</sup> were exhibited by QL1206. When compared to QL1206 with Xgeva<sup>®</sup>, the 90% confidence intervals of the ratios for C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> were"],"journal":["Frontiers in pharmacology"],"pagination":["01329"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC7580200"],"repository":["biostudies-literature"],"pubmed_title":["A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects."],"pmcid":["PMC7580200"],"pubmed_authors":["Li X","Wu M","Ding Y","Li C","Zhang H","Niu J","Liu Q","Zhu X","Liu C","Wei W","Sun J"],"additional_accession":[]},"is_claimable":false,"name":"A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects.","description":"<h4>Objective</h4>This study was conducted to explore the tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese subjects.<h4>Methods</h4>This is a randomized, double-blind, two-arm, parallel study performed to examine the bioequivalence of denosumab biosimilar, QL1206, with that of Xgeva<sup>®</sup> (Denosumab) as a reference drug. A single dose of 120 mg/kg of the denosumab biosimilar or Xgeva<sup>®</sup> was administered to the subjects, who were followed up for 134 days.<h4>Results</h4>Similar PK properties as those of Xgeva<sup>®</sup> were exhibited by QL1206. When compared to QL1206 with Xgeva<sup>®</sup>, the 90% confidence intervals of the ratios for C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> were","dates":{"release":"2020-01-01T00:00:00Z","publication":"2020","modification":"2026-05-01T00:49:52.993Z","creation":"2020-11-03T08:05:38Z"},"accession":"S-EPMC7580200","cross_references":{"pubmed":["33132906"],"doi":["10.3389/fphar.2020.01329"]}}