Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Evaluation of Safety, Tolerability, and Pharmacokinetic Properties of Salvianolic Acid A Tablets in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Percentage of participants with change from baseline in vital signs
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •(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.
研究组 & 干预措施
Experimental
干预措施: Salvianolic Acid A (Drug)
Placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Percentage of participants with change from baseline in vital signs
时间窗: 7 days
Heart rate, Blood Pressure，auxillary temperature
Change from baseline in electrocardiograms (ECGs)
时间窗: 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]
时间窗: 2 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax]
时间窗: 2 days
Subject incidence of treatment-emergent adverse events
时间窗: 7 days
PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax]
时间窗: 2 days
Percentage of participants with change from baseline in clinical laboratory parameters
时间窗: 7 days
blood routine, urine routine, biochemical parameters of blood and urine，coagulation tests
次要结局
未报告次要终点
研究者
Cui Yimin
Director of Pharmacy, M.D. and Ph.D.
Peking University First Hospital