M. Nakano, K. Uenaka, W. Kielbasa, Y. Matsuyama, Akichika Ozeki, M. Ayan-Oshodi
{"title":"降钙素基因相关肽单克隆抗体Galcanezumab在健康日本人和白种人中的安全性、耐受性、药代动力学和药效学","authors":"M. Nakano, K. Uenaka, W. Kielbasa, Y. Matsuyama, Akichika Ozeki, M. Ayan-Oshodi","doi":"10.3999/JSCPT.48.131","DOIUrl":null,"url":null,"abstract":"s : American Headache Society® 58th Annual Scientific Meeting. Headache. 2016; 56(Suppl 1) : PS29. doi : 10.1111/head. 12832. 17) Bourdage JS, Cook CA, Farrington DL, Chain JS, Konrad RJ. An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug. J Immunol Methods. 2007; 327 (1-2) : 10-17. doi : 10.1016/j.jim.2007.07.004. 18) de Hoon J, Monteith D, Vermeersch S, Van Hecken A, Abu-Raddad E, Collins E, et al. Safety, pharmacokinetics, and pharmacodynamics of LY2951742: a monoclonal antibody targeting CGRP. In : International Headache Congress 2013 Program of Abstracts. Cephalalgia. 2013; 33 (Suppl 8) : P367. doi : 10.1177/0333102413490487. 19) Miller B, Collins EC, Hodsdon M, Camporeale A, Nguyen H, Oakes T, et al. Evaluation of treatment-emergent anti-drug antibodies following administration of LY2951742, a calcitonin gene-related peptide antibody, to migraine patients. In : Program Abstracts : American Headache Society®58th Annual Scientific Meeting. Headache. 2016; 56(Suppl 1) : PS43. doi : 10.1111/head.12832. 20) Davda JP, Hansen RJ. Properties of a general PK/PD model of antibody-ligand interactions for therapeutic antibodies that bind to soluble endogenous targets. MAbs. 2010; 2 (5) : 576-88. doi : 10.4161/mabs.2.5.12833. NAKANO, et al. : Safety and PK of Galcanezumab in Japanese Subjects 139","PeriodicalId":21491,"journal":{"name":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","volume":"77 1","pages":"131-139"},"PeriodicalIF":0.0000,"publicationDate":"2017-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"3","resultStr":"{\"title\":\"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Galcanezumab, a Monoclonal Antibody to Calcitonin Gene-Related Peptide, in Healthy Japanese and Caucasian Subjects\",\"authors\":\"M. Nakano, K. Uenaka, W. Kielbasa, Y. Matsuyama, Akichika Ozeki, M. Ayan-Oshodi\",\"doi\":\"10.3999/JSCPT.48.131\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"s : American Headache Society® 58th Annual Scientific Meeting. Headache. 2016; 56(Suppl 1) : PS29. doi : 10.1111/head. 12832. 17) Bourdage JS, Cook CA, Farrington DL, Chain JS, Konrad RJ. An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug. J Immunol Methods. 2007; 327 (1-2) : 10-17. doi : 10.1016/j.jim.2007.07.004. 18) de Hoon J, Monteith D, Vermeersch S, Van Hecken A, Abu-Raddad E, Collins E, et al. Safety, pharmacokinetics, and pharmacodynamics of LY2951742: a monoclonal antibody targeting CGRP. In : International Headache Congress 2013 Program of Abstracts. Cephalalgia. 2013; 33 (Suppl 8) : P367. doi : 10.1177/0333102413490487. 19) Miller B, Collins EC, Hodsdon M, Camporeale A, Nguyen H, Oakes T, et al. Evaluation of treatment-emergent anti-drug antibodies following administration of LY2951742, a calcitonin gene-related peptide antibody, to migraine patients. In : Program Abstracts : American Headache Society®58th Annual Scientific Meeting. Headache. 2016; 56(Suppl 1) : PS43. doi : 10.1111/head.12832. 20) Davda JP, Hansen RJ. Properties of a general PK/PD model of antibody-ligand interactions for therapeutic antibodies that bind to soluble endogenous targets. MAbs. 2010; 2 (5) : 576-88. doi : 10.4161/mabs.2.5.12833. NAKANO, et al. : Safety and PK of Galcanezumab in Japanese Subjects 139\",\"PeriodicalId\":21491,\"journal\":{\"name\":\"Rinsho Yakuri\\\\/japanese Journal of Clinical Pharmacology and Therapeutics\",\"volume\":\"77 1\",\"pages\":\"131-139\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2017-07-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Rinsho Yakuri\\\\/japanese Journal of Clinical Pharmacology and Therapeutics\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3999/JSCPT.48.131\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Rinsho Yakuri\\/japanese Journal of Clinical Pharmacology and Therapeutics","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3999/JSCPT.48.131","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Galcanezumab, a Monoclonal Antibody to Calcitonin Gene-Related Peptide, in Healthy Japanese and Caucasian Subjects
s : American Headache Society® 58th Annual Scientific Meeting. Headache. 2016; 56(Suppl 1) : PS29. doi : 10.1111/head. 12832. 17) Bourdage JS, Cook CA, Farrington DL, Chain JS, Konrad RJ. An Affinity Capture Elution (ACE) assay for detection of anti-drug antibody to monoclonal antibody therapeutics in the presence of high levels of drug. J Immunol Methods. 2007; 327 (1-2) : 10-17. doi : 10.1016/j.jim.2007.07.004. 18) de Hoon J, Monteith D, Vermeersch S, Van Hecken A, Abu-Raddad E, Collins E, et al. Safety, pharmacokinetics, and pharmacodynamics of LY2951742: a monoclonal antibody targeting CGRP. In : International Headache Congress 2013 Program of Abstracts. Cephalalgia. 2013; 33 (Suppl 8) : P367. doi : 10.1177/0333102413490487. 19) Miller B, Collins EC, Hodsdon M, Camporeale A, Nguyen H, Oakes T, et al. Evaluation of treatment-emergent anti-drug antibodies following administration of LY2951742, a calcitonin gene-related peptide antibody, to migraine patients. In : Program Abstracts : American Headache Society®58th Annual Scientific Meeting. Headache. 2016; 56(Suppl 1) : PS43. doi : 10.1111/head.12832. 20) Davda JP, Hansen RJ. Properties of a general PK/PD model of antibody-ligand interactions for therapeutic antibodies that bind to soluble endogenous targets. MAbs. 2010; 2 (5) : 576-88. doi : 10.4161/mabs.2.5.12833. NAKANO, et al. : Safety and PK of Galcanezumab in Japanese Subjects 139