Phase I Study of Continuous Administration of Salvianolic Acid A Tablet
Status:
Unknown status
Trial end date:
2019-05-30
Target enrollment:
Participant gender:
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).The purpose of this study is to assess the
safety,tolerability, and pharmacokinetics (PK) of an extended dosing regimen ofsalvianolic
acid A: open label, continuous subcutaneous infusion for 7 days were tested as ascending
doses of salvianolic acid A from 90mg up to 180 mg.