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

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 observed to be within 80–125%. The inter-subject variability (inter-CV) ranged from 29% to 39.5%. Six and three subjects in the QL1206 and Xgeva(®) groups were found to be positive for the ADA and negative for the NAb, respectively. The CTX1 concentration-time profiles appeared similar (about 80% decrease from 48 hours to134 days) between the QL1206 and Xgeva(®) groups. Adverse events (AEs) were observed in 92.6% and 93.4% of subjects in the QL1206 and Xgeva(®) groups, respectively. Reduction in blood calcium level was found to be the most common AE recorded, with an incidence of 72.8% versus 72.4% in the QL1206 and Xgeva(®) groups, respectively. CONCLUSION: Similar PK and PD characteristics were exhibited by QL1206 as compared to those of Xgeva(®). The inter-CV was slightly large. The safety profiles of denosumab biosimilars and Xgeva(®) were found to be similar.