Phase I Study of Continuous Administration of Salvianolic Acid A Tablet
- Registration Number
- NCT03908242
- 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).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.
- Detailed Description
This was a Phase I repeated incremental doses study in healthy volunteers. A total of 24 subjects was planned to be enrolled. This was performed according to a double blind, randomized, placebo controlled design and included two sequential dose groups of repeat doses. Each group enrolled 12 subjects on salvianolic acid A or placebo (ratio 9 experimental: 3 placebo) and received salvianolic acid A or placebo twice daily (90mg) or daily (180mg) for 7 days, and follow-up to 3 or 4 days.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 24
-
- 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
- PARALLEL
- Arm && Interventions
Group Intervention Description Salvianolic Acid A salvianolic acid A 2 anticipated doses are 90 mg and 180 mg. Placebo Oral Tablet Placebo Placebo tablets containing no salvianolic acid A will be given to healthy subjects.
- Primary Outcome Measures
Name Time Method Subject incidence of treatment-emergent adverse events 10 or 11 days Percentage of participants with change from baseline in vital signs 10 or 11 days Heart rate, Blood Pressure，auxillary temperature
Percentage of participants with change from baseline in clinical laboratory parameters 10 or 11 days blood routine, urine routine, biochemical parameters of blood and urine，coagulation tests
Plasma concentrations of salvianolic acid A 8 days To investigate the pharmacokinetics (PK) profile of multiple ascending doses of salvianolic acid A
Change from baseline in electrocardiograms (ECGs) 10 or 11 days PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Xiaocong Pang
🇨🇳Beijing, China