Phase I Single-dose Escalation Clinical Trial of Salvianolic Acid A Tablets
- Conditions
- Neuropathy of Diabetes
- Interventions
- Drug: Placebo Oral Tablet
- Registration Number
- NCT03791125
- Lead Sponsor
- Peking University First Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
-
- Gender: male or female, healthy volunteers; 2) Age: 18~45 years old; 3) Weight: Male subjects need to weigh ≥ 50kg, female subjects should have ≥ 45kg, body mass index [BMI = weight (kg) / height 2 (m2)] in the range of 19 ~ 25 kg / m2; 4) Subjects must give informed consent to the trial prior to the trial and voluntarily sign a written informed consent form; 5) The subject is able to communicate well with the investigator and is able to complete the trial in accordance with the protocol.
- (1) Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus and syphilis positive; (2) alcoholics; (3) subjects who took any drug or long-term use of drugs within 2 weeks before screening (4) Blood donors within 3 months prior to the trial; (5) participated in any drug clinical trial within 3 months prior to screening; (6) had a clear history of allergic disease; (7) had central nervous system, cardiovascular Systematic, kidney, liver, digestive tract, lung disease, metabolic and skeletal muscle system with a clear history or other significant disease; (8) pregnant, lactating women; (9) other factors not suitable for participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo Placebo Oral Tablet - Experimental Salvianolic Acid A -
- Primary Outcome Measures
Name Time Method Percentage of participants with change from baseline in vital signs 7 days Heart rate, Blood Pressure，auxillary temperature
Change from baseline in electrocardiograms (ECGs) 7 days PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
PK profile of Salvianolic acid A following administration of multiple doses assessed by area under the curve [AUC] 2 days PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax] 2 days Subject incidence of treatment-emergent adverse events 7 days PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax] 2 days Percentage of participants with change from baseline in clinical laboratory parameters 7 days blood routine, urine routine, biochemical parameters of blood and urine，coagulation tests
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Department of Pharmacy, Base for Clinical Trial, Peking University First Hospital
🇨🇳Beijing, Beijing, China