Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Galcanezumab, a Monoclonal Antibody to Calcitonin Gene-Related Peptide, in Healthy Japanese and Caucasian Subjects

Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics Pub Date : 2017-07-31 DOI:10.3999/JSCPT.48.131

M. Nakano, K. Uenaka, W. Kielbasa, Y. Matsuyama, Akichika Ozeki, M. Ayan-Oshodi

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引用次数: 3

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

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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

5:美国头痛学会第58届年度科学会议。头痛。2016;56(增刊1):PS29。Doi: 10.1111/head。12832. 17)刘建军，刘建军，刘建军，刘建军。亲和捕获洗脱(ACE)法用于检测单克隆抗体治疗药物在高水平药物存在下的抗药物抗体。中华免疫学杂志。2007;327(1-2): 10-17。Doi: 10.1016/j.jim.2007.07.004。18)德勋J，王晓明，王晓明，等。靶向CGRP的单克隆抗体LY2951742的安全性、药代动力学和药效学见:2013年国际头痛大会摘要计划。头痛。2013;33(增刊8):P367。Doi: 10.1177/0333102413490487。[19]刘建军，刘建军，刘建军，等。评估偏头痛患者服用LY2951742(一种降钙素基因相关肽抗体)后出现的抗药物抗体。项目摘要:美国头痛学会第58届年度科学会议。头痛。2016;56(增刊1):PS43。Doi: 10.1111/head.12832。[20]张建平，李建平。结合可溶性内源性靶标的治疗性抗体-配体相互作用的一般PK/PD模型的性质。马伯。2010;2(5): 576-88。Doi: 10.4161/mabs.2.5.12833。Galcanezumab在日本受试者中的安全性和PK [39]

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$Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics$

Rinsho Yakuri\/japanese Journal of Clinical Pharmacology and Therapeutics

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