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

Study Overview
=================
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.

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Evaluation of Safety, Tolerability, and Pharmacokinetic Properties of Salvianolic Acid A Tablets in Healthy Volunteers

Conditions
-----------------
Neuropathy of Diabetes

Intervention / Treatment
-----------------
* Drug: Salvianolic Acid A
* Drug: Placebo Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) 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. Exclusion Criteria: (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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Drug: Salvianolic Acid A<br>* 4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo Oral Tablet<br>* Placebo tablets containing no salvianolic acid A will be given to healthy subjects.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject incidence of treatment-emergent adverse events |  | 7 days | 
| Percentage of participants with change from baseline in vital signs | Heart rate, Blood Pressure，auxillary temperature | 7 days | 
| Change from baseline in electrocardiograms (ECGs) | PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities | 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 | 7 days | 
| 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 maximum observed concentration [Cmax] |  | 2 days | 
| PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax] |  | 2 days |