Pharmacokinetics, pharmacodynamics, safety and immunogenicity of recombinant, fully human anti-RANKL monoclonal antibody (MW031) versus denosumab in Chinese healthy subjects: a single-center, randomized, double-blind, single-dose, parallel-controlled trial

最大值 药代动力学 医学 药效学 生物等效性 德诺苏马布 免疫原性 药理学 临床终点 不利影响 置信区间 随机对照试验 内科学 免疫学 抗体 骨质疏松症
作者
Yinhan Guo,Tingting Guo,Yujing Di,Wenyu Xu,Zhitian Hu,Yanfeng Xiao,Heze Yu,Jie Hou
出处
期刊:Expert Opinion on Biological Therapy [Taylor & Francis]
卷期号:23 (8): 705-715 被引量:5
标识
DOI:10.1080/14712598.2023.2178298
摘要

Background MW031 is a biosimilar candidate of denosumab (Prolia®). This study aimed to compare the pharmacokinetics, pharmacodynamics, safety and immunogenicity of MW031 to denosumab in healthy Chinese participants.Research design and methods In this single-center, randomized, double-blind, parallel-controlled, single-dose trial, participants were given 60 mg MW031 (N = 58) or denosumab (N = 61) by subcutaneous injection and observed for 140 days. The primary endpoint was the bioequivalence of PK parameters (Cmax, AUC0-∞), and secondary endpoints including PD parameter, safety, and immunogenicity.Results A comparison of main PK parameters showed that the geometric mean ratios (GMR) (90% confidence intervals [CIs]) of AUC0-∞ and Cmax for MW031 over denosumab were 105.48% (98.96%, 112.43%) and 98.58% (92.78%, 104.75%), respectively. The inter-CV values of AUC0-∞ and Cmax for MW031 ranged from 19.9% to 23.1%. PD parameter (sCTX) in the MW031 and denosumab groups were similar, and the positivity rates of immunogenicity were 0% in both groups. This study also showed similar safety profiles in both groups, and there were no drug-related, high-incidence and previously unreported adverse reactions.Conclusion This trial confirmed similar pharmacokinetic profiles of MW031 and denosumab in healthy male participants, and pharmacodynamic profile, immunogenicity and safety were comparable for both drugs.Trial registration NCT04798313; CTR20201149
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