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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study.
Placebo tablets containing no salvianolic acid A will be given to healthy subjects.
Department of Pharmacy, Base for Clinical Trial, Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGSubject incidence of treatment-emergent adverse events
Time frame: 7 days
Percentage of participants with change from baseline in vital signs
Heart rate, Blood Pressure,auxillary temperature
Time frame: 7 days
Change from baseline in electrocardiograms (ECGs)
PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
Time frame: 7 days
Percentage of participants with change from baseline in clinical laboratory parameters
blood routine, urine routine, biochemical parameters of blood and urine,coagulation tests
Time frame: 7 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by area under the curve [AUC]
Time frame: 2 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax]
Time frame: 2 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax]
Time frame: 2 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.