drugset / Trial / NCT03791125

Phase I Single-dose Escalation Clinical Trial of Salvianolic Acid A Tablets

NCT03791125 ↗

RandomizedSingle-groupTriple-blindTreatment

Summary

Salvianolic acid A has a variety of pharmacological effects, such as: anti-oxidation, scavenging oxygen free radicals, anti-fibrosis, anti-myocardial ischemia, anti-coagulation, anti-thrombosis, anti-tumor, etc. Professor Du Guanhua, at Institue of Materia Medica, Chinese Academy of Medical Sciences, first discovered that salvianolic acid A can alleviate diabetic complications and improve patients' quality of life. With the support of major national science and technology projects, the preclinical research work of salvianolic acid A was completed, and the application was approved by the State Food and Drug Administration (Clinical Approval No.: 2016L06293). Peking University First Hospital was used as the research unit. This study is the first human clinical trial of the drug. The project leader of this study is Professor Cui Yimin from Peking University First Hospital. The sponsor of this project is Shandong Huizhi Pharmaceutical Technology Co., Ltd.

Timeline

Start
2018-11-20
Primary completion
2019-03-20
Completion
2019-05-20

Drugs

EvaluationDrugModalityDoseRoute
Subject salvianolic acid A Small molecule 30 mg —
Subject salvianolic acid A Small molecule 90 mg —
Subject salvianolic acid A Small molecule 180 mg —
Subject salvianolic acid A Small molecule 270 mg —

Indications