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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salvianolic Acid A | Experimental | 2 anticipated doses are 90 mg and 180 mg. |
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| Placebo Oral Tablet | Placebo Comparator | Placebo tablets containing no salvianolic acid A will be given to healthy subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salvianolic acid A | Drug | salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject incidence of treatment-emergent adverse events | 10 or 11 days | |
| Percentage of participants with change from baseline in vital signs | Heart rate, Blood Pressure,auxillary temperature | 10 or 11 days |
| Change from baseline in electrocardiograms (ECGs) | PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities | 10 or 11 days |
| Percentage of participants with change from baseline in clinical laboratory parameters | blood routine, urine routine, biochemical parameters of blood and urine,coagulation tests | 10 or 11 days |
| Plasma concentrations of salvianolic acid A | To investigate the pharmacokinetics (PK) profile of multiple ascending doses of salvianolic acid A | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaocong Pang, Ph.D | Contact | +861066110802 | xiaocong.pang@pkufh.com | |
| Nan Zhao, M.D | Contact | +861066110802 | 790837037@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Yimin Cui, Ph.D | Peking University First Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiaocong Pang | Beijing | 100034 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C066201 | salvianolic acid A |
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| Placebo | Drug | salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd |
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