biostudies-literatureUnknown11Zhang H<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^® (Denosumab) as a reference drug. A single dose of 120 mg/kg of the denosumab biosimilar or Xgeva^® was administered to the subjects, who were followed up for 134 days.<h4>Results</h4>Similar PK properties as those of Xgeva^® were exhibited by QL1206. When compared to QL1206 with Xgeva^®, the 90% confidence intervals of the ratios for C_max, AUC_0-t, and AUC_0-∞ wereFrontiers in pharmacology01329https://www.ebi.ac.uk/biostudies/studies/S-EPMC7580200biostudies-literatureA Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects.PMC7580200Li XWu MDing YLi CZhang HNiu JLiu QZhu XLiu CWei WSun JfalseA Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of QL1206 to Denosumab Among Chinese Healthy Subjects.<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^® (Denosumab) as a reference drug. A single dose of 120 mg/kg of the denosumab biosimilar or Xgeva^® was administered to the subjects, who were followed up for 134 days.<h4>Results</h4>Similar PK properties as those of Xgeva^® were exhibited by QL1206. When compared to QL1206 with Xgeva^®, the 90% confidence intervals of the ratios for C_max, AUC_0-t, and AUC_0-∞ were2020-01-01T00:00:00Z20202026-05-01T00:49:52.993Z2020-11-03T08:05:38ZS-EPMC75802003313290610.3389/fphar.2020.01329