Diabetes
Conditions
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.
Interventions
salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd
DRUGPlacebo
salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change from baseline in electrocardiograms (ECGs) | 10 or 11 days | PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities |
| 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 |
Countries
China
Contacts
Primary ContactXiaocong Pang, Ph.D
Backup ContactNan Zhao, M.D
Outcome results
None listed