XiangYa School of Pharmaceutical Sciences, Central South University, Changsha, China.
Center of Clinical Pharmacology, the Third Xiangya Hospital, Central South University, Changsha, China.
Expert Opin Investig Drugs. 2022 Oct;31(10):1133-1142. doi: 10.1080/13543784.2022.2120389. Epub 2022 Sep 7.
To compare the pharmacokinetics (PK), pharmacodynamics (PD), safety, and immunogenicity of LY06006 (denosumab biosimilar) and denosumab in healthy Chinese adult male subjects.
In this randomized, double-blind, parallel-controlled, single-dose, comparative biosimilar study, a total of 168 subjects received 60 mg of LY06006 or denosumab by subcutaneous (SC) abdominal injections in a 1:1 ratio with a follow-up period of 168 days.
After a single SC abdominal injection of 60 mg LY06006/denosumab, the geometric mean ratio of the main pharmacokinetic parameters, C and AUC of the two drugs were 97.57% and 104.27%, respectively; the geometric mean ratio of the main pharmacodynamic parameters AUEC and E, were 101.00% and 99.64%, respectively, and the 90% confidence interval was observed to be within 80-125%. The subjects in the test group (LY06006) and control group (denosumab) were all negative for anti-drug antibody (ADA). The incidence and severity of treatment-emergent adverse events (TEAEs)were similar for both groups, and no grade 3 or higher TEAEs occurred in either group.
This study demonstrated that LY06006 and denosumab have similar characteristics and bioequivalence in pharmacokinetics. Moreover, they had similar pharmacodynamic profiles, safety, and immunogenicity.
www.clinicaltrials.gov identifier is NCT04973722.
比较 LY06006（地舒单抗生物类似药）和地舒单抗在中国健康成年男性受试者中的药代动力学（PK）、药效学（PD）、安全性和免疫原性。
在这项随机、双盲、平行对照、单次剂量、比较生物类似药研究中，168 名受试者按 1:1 的比例接受 60 mg 的 LY06006 或地舒单抗皮下（SC）腹部注射，随访期为 168 天。
单次 SC 腹部注射 60 mg LY06006/地舒单抗后，两药的主要 PK 参数 C 和 AUC 的几何均数比分别为 97.57%和 104.27%；主要 PD 参数 AUEC 和 E 的几何均数比分别为 101.00%和 99.64%，90%置信区间观察值在 80%-125%范围内。试验组（LY06006）和对照组（地舒单抗）的受试者均未检测到抗药物抗体（ADA）。两组的治疗中出现的不良事件（TEAE）的发生率和严重程度相似，两组均未发生 3 级或更高级别的 TEAEs。
本研究表明，LY06006 与地舒单抗在 PK 方面具有相似的特性和生物等效性。此外，它们具有相似的药效学特征、安全性和免疫原性。
www.clinicaltrials.gov 标识符为 NCT04973722。
