Considerations for cardiac safety risk management in phase Ⅰ clinical trials of sphingosine phosphate receptor 1 modulators
10.13699/j.cnki.1001-6821.2024.11.022
- VernacularTitle: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
- Author:
Xiao-Meng MAO
1
;
Jing ZHANG
;
Hai-Jing YANG
;
Jing-Jing WANG
Author Information
1. 复旦大学附属华山医院临床药理研究中心,上海 200040
- Keywords:
sphingosine 1-phosphate receptor 1 modulator;
cardiac safety;
risk management;
phase Ⅰ clinical trial
- From:
The Chinese Journal of Clinical Pharmacology
2024;40(11):1646-1649
- CountryChina
- Language:Chinese
-
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.
