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Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a biosimilar of denosumab (LY06006): a randomized, double-blind, single-dose, parallel-controlled clinical study in healthy Chinese subjects. 2022

Siyi Wang, and Xiaoyan Yang, and Jie Huang, and Shuang Yang, and Qian Wu, and Honghui Chen, and Shuting Wu, and Changlin Dou, and Guoping Yang, and Yuxia Xiang
XiangYa School of Pharmaceutical Sciences, Central South University, Changsha, China.

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, Cmax and AUC0-∞, of the two drugs were 97.57% and 104.27%, respectively; the geometric mean ratio of the main pharmacodynamic parameters AUEC0-t and Emax, 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.

UI MeSH Term Description Entries
D008297 Male Males
D002681 China A country spanning from central Asia to the Pacific Ocean. Inner Mongolia,Manchuria,People's Republic of China,Sinkiang,Mainland China
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000069448 Denosumab A humanized monoclonal antibody and an inhibitor of the RANK LIGAND, which regulates OSTEOCLAST differentiation and bone remodeling. It is used as a BONE DENSITY CONSERVATION AGENT in the treatment of OSTEOPOROSIS. AMG 162,Prolia,Xgeva
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000906 Antibodies Immunoglobulin molecules having a specific amino acid sequence by virtue of which they interact only with the ANTIGEN (or a very similar shape) that induced their synthesis in cells of the lymphoid series (especially PLASMA CELLS).
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D059451 Biosimilar Pharmaceuticals Biological products that are imitations but not exact replicas of innovator biological products. Biosimilar,Biosimilars,Follow-on Biologics,Subsequent Entry Biologics,Biologics, Follow-on,Biologics, Subsequent Entry,Follow on Biologics,Pharmaceuticals, Biosimilar
D019540 Area Under Curve A statistical means of summarizing information from a series of measurements on one individual. It is frequently used in clinical pharmacology where the AUC from serum levels can be interpreted as the total uptake of whatever has been administered. As a plot of the concentration of a drug against time, after a single dose of medicine, producing a standard shape curve, it is a means of comparing the bioavailability of the same drug made by different companies. (From Winslade, Dictionary of Clinical Research, 1992) AUC,Area Under Curves,Curve, Area Under,Curves, Area Under,Under Curve, Area,Under Curves, Area

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