Yanli Wang, Zhengzhi Liu, Qiaohuan Deng, Zhengjie Su, Jinling Xue, Yicheng Zhao, Haimiao Yang
{"title":"在健康受试者中进行随机、单盲、单剂量、平行组研究，以证明曲妥珠单抗及其生物类似药的药代动力学等效性。","authors":"Yanli Wang, Zhengzhi Liu, Qiaohuan Deng, Zhengjie Su, Jinling Xue, Yicheng Zhao, Haimiao Yang","doi":"10.1080/17425255.2023.2243823","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Trastuzumab is a humanized anti-HER2 monoclonal antibody used in the treatment of breast cancer. This study compared the pharmacokinetics (PK), immunogenicity and safety of trastuzumab (Roche Pharma AG) and its biosimilar (Chia Tai Tianqing Pharmaceutical Group Co. Ltd) in healthy Chinese subjects.</p><p><strong>Research design and methods: </strong>A randomized, parallel, double-blind, single-dose study was conducted. Healthy male subjects were randomized to receive trastuzumab (<i>n</i> = 43) or its biosimilar (<i>n</i> = 43) intravenously at a dose of 4 mg. Plasma drug concentrations were detected by enzyme-linked immunosorbent assay (ELISA), and PK parameters were statistically analyzed. Safety and immunogenicity were also evaluated.</p><p><strong>Results: </strong>The geometric mean ratios (GMRs) of AUC<sub>0-t</sub>, C<sub>max</sub> and AUC<sub>0-∞</sub> for trastuzumab and its biosimilar were 92.3%, 100.77% and 92.2%, respectively. The 90% CIs were all within 80%-125%, meeting the bioequivalence standards. No serious adverse events or immunogenicity were reported, and all the adverse events reported were mild and similar between the two treatment groups.</p><p><strong>Conclusions: </strong>Trastuzumab was well tolerated, showed a similar safety profile to its biosimilar, and demonstrated PK equivalence.</p><p><strong>Clinical trial registration: </strong>This trial was registered at the [anonymized].</p>","PeriodicalId":12250,"journal":{"name":"Expert Opinion on Drug Metabolism & Toxicology","volume":" ","pages":"849-855"},"PeriodicalIF":3.9000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A randomized, single-blind, single-dose, parallel-group study in healthy subjects to demonstrate the pharmacokinetic equivalence of trastuzumab and its biosimilar.\",\"authors\":\"Yanli Wang, Zhengzhi Liu, Qiaohuan Deng, Zhengjie Su, Jinling Xue, Yicheng Zhao, Haimiao Yang\",\"doi\":\"10.1080/17425255.2023.2243823\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Trastuzumab is a humanized anti-HER2 monoclonal antibody used in the treatment of breast cancer. 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No serious adverse events or immunogenicity were reported, and all the adverse events reported were mild and similar between the two treatment groups.</p><p><strong>Conclusions: </strong>Trastuzumab was well tolerated, showed a similar safety profile to its biosimilar, and demonstrated PK equivalence.</p><p><strong>Clinical trial registration: </strong>This trial was registered at the [anonymized].</p>\",\"PeriodicalId\":12250,\"journal\":{\"name\":\"Expert Opinion on Drug Metabolism & Toxicology\",\"volume\":\" \",\"pages\":\"849-855\"},\"PeriodicalIF\":3.9000,\"publicationDate\":\"2023-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Expert Opinion on Drug Metabolism & Toxicology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/17425255.2023.2243823\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/8/3 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q2\",\"JCRName\":\"BIOCHEMISTRY & MOLECULAR BIOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Expert Opinion on Drug Metabolism & Toxicology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/17425255.2023.2243823","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/8/3 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
A randomized, single-blind, single-dose, parallel-group study in healthy subjects to demonstrate the pharmacokinetic equivalence of trastuzumab and its biosimilar.
Background: Trastuzumab is a humanized anti-HER2 monoclonal antibody used in the treatment of breast cancer. This study compared the pharmacokinetics (PK), immunogenicity and safety of trastuzumab (Roche Pharma AG) and its biosimilar (Chia Tai Tianqing Pharmaceutical Group Co. Ltd) in healthy Chinese subjects.
Research design and methods: A randomized, parallel, double-blind, single-dose study was conducted. Healthy male subjects were randomized to receive trastuzumab (n = 43) or its biosimilar (n = 43) intravenously at a dose of 4 mg. Plasma drug concentrations were detected by enzyme-linked immunosorbent assay (ELISA), and PK parameters were statistically analyzed. Safety and immunogenicity were also evaluated.
Results: The geometric mean ratios (GMRs) of AUC0-t, Cmax and AUC0-∞ for trastuzumab and its biosimilar were 92.3%, 100.77% and 92.2%, respectively. The 90% CIs were all within 80%-125%, meeting the bioequivalence standards. No serious adverse events or immunogenicity were reported, and all the adverse events reported were mild and similar between the two treatment groups.
Conclusions: Trastuzumab was well tolerated, showed a similar safety profile to its biosimilar, and demonstrated PK equivalence.
Clinical trial registration: This trial was registered at the [anonymized].
期刊介绍：
Expert Opinion on Drug Metabolism & Toxicology (ISSN 1742-5255 [print], 1744-7607 [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing review articles on all aspects of ADME-Tox. Each article is structured to incorporate the author’s own expert opinion on the scope for future development.
The Editors welcome:
Reviews covering metabolic, pharmacokinetic and toxicological issues relating to specific drugs, drug-drug interactions, drug classes or their use in specific populations; issues relating to enzymes involved in the metabolism, disposition and excretion of drugs; techniques involved in the study of drug metabolism and toxicology; novel technologies for obtaining ADME-Tox data.
Drug Evaluations reviewing the clinical, toxicological and pharmacokinetic data on a particular drug.
The audience consists of scientists and managers in the pharmaceutical industry, pharmacologists, clinical toxicologists and related professionals.
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