Phase I Study of Continuous Administration of Salvianolic Acid A Tablet

NCT ID: NCT03908242

Last Updated: 2019-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-08
• Study Completion Date: 2019-05-30

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Salvianolic Acid A

2 anticipated doses are 90 mg and 180 mg.

Group Type: EXPERIMENTAL

salvianolic acid A

Intervention Type: DRUG

salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd

Placebo Oral Tablet

Placebo tablets containing no salvianolic acid A will be given to healthy subjects.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd

Interventions

salvianolic acid A

salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd

Intervention Type: DRUG

Placebo

salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cui Yimin

Director of Pharmacy, M.D. and Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yimin Cui, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Peking University First Hospital

Locations

Xiaocong Pang

Beijing, , China

Countries

China

Central Contacts

Xiaocong Pang, Ph.D

Role: CONTACT

xiaocong.pang@pkufh.com

+861066110802

Nan Zhao, M.D

Role: CONTACT

790837037@qq.com

+861066110802

Facility Contacts

Xiaocong Pang, Ph.D

Role: primary

xiaocong.pang@pkufh.com

+861066110802

Other Identifiers

SAA003

Identifier Type: -

Identifier Source: org_study_id