中国临床药理学杂志2024，Vol.40Issue(11)：1646-1649,4.DOI:10.13699/j.cnki.1001-6821.2024.11.022
1-磷酸鞘氨醇受体1调节药在新药Ⅰ期临床试验中心脏安全性风险管控的考量
Considerations for cardiac safety risk management in phase Ⅰ clinical trials of sphingosine phosphate receptor 1 modulators
摘要
Abstract
Sphingosine 1-phosphate receptor 1(S1PR1)is currently a popular research target for the treatment of immune-related diseases,but it also has potential cardiac safety risks.This article summarizes the experience of the completed phase Ⅰ clinical trial of S1PR1 innovative drug and discusses the necessity and implementation points of cardiac safety risk management and control in the phase Ⅰ clinical trial of S1PR1 innovative drug by summarizing the experience of the completed phase Ⅰclinical trial of S1PR1 innovative drug,combined with the guiding principles of risk identification and control strategy for early clinical trial and clinical evaluation of drug QT at home and abroad,for the reference of the industry.关键词
1-磷酸鞘氨醇受体1调节药/心脏安全性/风险管控/Ⅰ期临床试验Key words
sphingosine 1-phosphate receptor 1 modulator/cardiac safety/risk management/phase Ⅰ clinical trial分类
医药卫生引用本文复制引用
毛肖萌,张菁,杨海静,王晶晶..1-磷酸鞘氨醇受体1调节药在新药Ⅰ期临床试验中心脏安全性风险管控的考量[J].中国临床药理学杂志,2024,40(11):1646-1649,4.基金项目
国家自然科学基金委重点研究计划基金资助项目(92169212) （92169212）
上海市科委生物医药科技支撑基金资助项目(22S11904102) （22S11904102）
