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

ABSTRACT:

Objective

This study was conducted to explore the tolerance, variability, pharmacokinetics (PK), and pharmacodynamics (PD) of denosumab biosimilar (QL1206) in healthy Chinese subjects.

Methods

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.

Results

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-∞ were

SUBMITTER: Zhang H 

PROVIDER: S-EPMC7580200 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature