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 phaseⅠclinical trials of sphingosine phosphate receptor 1 modulators

1-磷酸鞘氨醇受体1(S1PR1)是目前治疗免疫相关性疾病的热门研究靶点,但也存在潜在的心脏安全风险。本文通过对已完成的1.1类创新药S1PR1调节药Ⅰ期临床试验实施经验进行总结,结合国内外关于早期临床试验风险识别及控制策略、药物QT临床评价等指导原则,探讨在S1PR1创新药Ⅰ期临床试验过程中进行心脏安全性风险管控的必要性及实施要点,供业界参考。

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 phaseⅠclinical trial of S1PR1 innovative drug and discusses the necessity and implementation points of cardiac safety risk management and control in the phaseⅠclinical trial of S1PR1 innovative drug by summarizing the experience of the completed phaseⅠclinical 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.