Phase I Study of Continuous Administration of Salvianolic Acid A Tablet

Diabetes Clinical Trial

Official title:

Randomized, Double-blind, Placebo-controlled, Continuous Dosing, Single-center, Evaluation of Safety, Tolerability, and Pharmacokinetic Properties of Salvianolic Acid A Tablets in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03908242
• Other study ID #: SAA003
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 8, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: April 2019
• Source: Peking University First Hospital
• Contact: Xiaocong Pang, Ph.D
• Phone: +861066110802
• Email: xiaocong.pang[@]pkufh.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: May 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes

Intervention

Drug:
• salvianolic acid A
salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd
• Placebo
salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd

Locations

Country	Name	City	State
China	Xiaocong Pang	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject incidence of treatment-emergent adverse events		10 or 11 days
Primary	Percentage of participants with change from baseline in vital signs	Heart rate, Blood Pressure,auxillary temperature	10 or 11 days
Primary	Change from baseline in electrocardiograms (ECGs)	PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities	10 or 11 days
Primary	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
Primary	Plasma concentrations of salvianolic acid A	To investigate the pharmacokinetics (PK) profile of multiple ascending doses of salvianolic acid A	8 days