Zhengzhi Liu, Zhenyue Gao, Wei Yang, Lixiu Zhang, Nan Xiao, Dongmei Qu, Zhengjie Su, Kaibo Xu, Guangwen Liu, Yanli Wang, Qing Ren, Shuang Yu, Yang Cheng, Yannan Zhou, Qiaohuan Deng, Yicheng Zhao, Zeyu Wang, Haimiao Yang
{"title":"一项随机、双盲、单剂量、平行的I期临床试验，比较贝伐单抗生物仿制药和贝伐单抗在中国健康受试者中的生物等效性、免疫原性和安全性。","authors":"Zhengzhi Liu, Zhenyue Gao, Wei Yang, Lixiu Zhang, Nan Xiao, Dongmei Qu, Zhengjie Su, Kaibo Xu, Guangwen Liu, Yanli Wang, Qing Ren, Shuang Yu, Yang Cheng, Yannan Zhou, Qiaohuan Deng, Yicheng Zhao, Zeyu Wang, Haimiao Yang","doi":"10.1080/17425255.2022.2113382","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Bevacizumab, a humanized monoclonal antibody against VEGF, can be used as a target therapy for colorectal cancer. A phase I clinical trial was conducted to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and Bevacizumab (Roche Diagnostics GmbH) in healthy Chinese males.</p><p><strong>Research design & method: </strong>Healthy Chinese subjects (N = 98) were randomly divided into two groups. A single-dose bevacizumab biosimilar or Bevacizumab was given per cycle. Plasma drug concentrations were detected by liquid chromatography-tandem mass spectrometry (LC-MC/MS) assay. We detected the levels of anti-drug antibody (ADA) to evaluate drug immunogenicity and the safety of drugs throughout the study.</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 bevacizumab biosimilar and Bevacizumab were 96.27%, 93.69%, and 97.01%, respectively. The 90% CIs were all within 80-125%, meeting the bioequivalence standards. The levels of ADA were similar. In addition, the two drugs both demonstrated excellent safety in the trial.</p><p><strong>Conclusion: </strong>This study showed that bevacizumab biosimilar and Bevacizumab had similar pharmacokinetics (PK) parameters and safety in healthy Chinese subjects.</p>","PeriodicalId":12250,"journal":{"name":"Expert Opinion on Drug Metabolism & Toxicology","volume":" ","pages":"519-527"},"PeriodicalIF":3.4000,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A randomized, double-blind, single-dose, parallel phase I clinical trial to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar and bevacizumab in healthy Chinese subjects.\",\"authors\":\"Zhengzhi Liu, Zhenyue Gao, Wei Yang, Lixiu Zhang, Nan Xiao, Dongmei Qu, Zhengjie Su, Kaibo Xu, Guangwen Liu, Yanli Wang, Qing Ren, Shuang Yu, Yang Cheng, Yannan Zhou, Qiaohuan Deng, Yicheng Zhao, Zeyu Wang, Haimiao Yang\",\"doi\":\"10.1080/17425255.2022.2113382\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Bevacizumab, a humanized monoclonal antibody against VEGF, can be used as a target therapy for colorectal cancer. A phase I clinical trial was conducted to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and Bevacizumab (Roche Diagnostics GmbH) in healthy Chinese males.</p><p><strong>Research design & method: </strong>Healthy Chinese subjects (N = 98) were randomly divided into two groups. A single-dose bevacizumab biosimilar or Bevacizumab was given per cycle. Plasma drug concentrations were detected by liquid chromatography-tandem mass spectrometry (LC-MC/MS) assay. We detected the levels of anti-drug antibody (ADA) to evaluate drug immunogenicity and the safety of drugs throughout the study.</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 bevacizumab biosimilar and Bevacizumab were 96.27%, 93.69%, and 97.01%, respectively. The 90% CIs were all within 80-125%, meeting the bioequivalence standards. The levels of ADA were similar. In addition, the two drugs both demonstrated excellent safety in the trial.</p><p><strong>Conclusion: </strong>This study showed that bevacizumab biosimilar and Bevacizumab had similar pharmacokinetics (PK) parameters and safety in healthy Chinese subjects.</p>\",\"PeriodicalId\":12250,\"journal\":{\"name\":\"Expert Opinion on Drug Metabolism & Toxicology\",\"volume\":\" \",\"pages\":\"519-527\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2022-07-01\",\"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/10.1080/17425255.2022.2113382\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/8/18 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/10.1080/17425255.2022.2113382","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/8/18 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"BIOCHEMISTRY & MOLECULAR BIOLOGY","Score":null,"Total":0}
A randomized, double-blind, single-dose, parallel phase I clinical trial to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar and bevacizumab in healthy Chinese subjects.
Background: Bevacizumab, a humanized monoclonal antibody against VEGF, can be used as a target therapy for colorectal cancer. A phase I clinical trial was conducted to compare the bioequivalence, immunogenicity, and safety of bevacizumab biosimilar (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and Bevacizumab (Roche Diagnostics GmbH) in healthy Chinese males.
Research design & method: Healthy Chinese subjects (N = 98) were randomly divided into two groups. A single-dose bevacizumab biosimilar or Bevacizumab was given per cycle. Plasma drug concentrations were detected by liquid chromatography-tandem mass spectrometry (LC-MC/MS) assay. We detected the levels of anti-drug antibody (ADA) to evaluate drug immunogenicity and the safety of drugs throughout the study.
Results: The geometric mean ratios (GMRs) of AUC0-t, Cmax, and AUC0-∞ for bevacizumab biosimilar and Bevacizumab were 96.27%, 93.69%, and 97.01%, respectively. The 90% CIs were all within 80-125%, meeting the bioequivalence standards. The levels of ADA were similar. In addition, the two drugs both demonstrated excellent safety in the trial.
Conclusion: This study showed that bevacizumab biosimilar and Bevacizumab had similar pharmacokinetics (PK) parameters and safety in healthy Chinese subjects.
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.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
