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

Overview

Journal Front Pharmacol

Date 2020 Nov 2

PMID 33132906

Citations 10

Authors

Hong Zhang

Min Wu

Xiaoxue Zhu

Cuiyun Li

Xiaojiao Li

Jixuan Sun

Chengjiao Liu

Quan Liu

Wei Wei

Junqi Niu

Yanhua Ding

Affiliations

Soon will be listed here.

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, AUC, and AUC 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.

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