Phase I Single-dose Escalation Clinical Trial of Salvianolic Acid A Tablets

NCT ID: NCT03791125

Last Updated: 2019-01-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-20
• Study Completion Date: 2019-05-20

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). Peking University First Hospital was used as the research unit. This study is the first human clinical trial of the drug. The project leader of this study is Professor Cui Yimin from Peking University First Hospital. The sponsor of this project is Shandong Huizhi Pharmaceutical Technology Co., Ltd.

Conditions

Neuropathy of Diabetes

Study Design

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

Study Groups

Experimental

Group Type: EXPERIMENTAL

Salvianolic Acid A

Intervention Type: DRUG

4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type: DRUG

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

Interventions

Salvianolic Acid A

4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study.

Intervention Type: DRUG

Placebo Oral Tablet

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

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

Shandong Huizhi Pharmaceutical Technology Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cui Yimin

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Pharmacy, Base for Clinical Trial, Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaocong Pang, Ph.D.

Role: CONTACT

pangxiaocong1227@163.com

010-66110802

Facility Contacts

Xiaocong Pang, Ph.D.

Role: primary

pangxiaocong1227@163.com

010-66110802

Other Identifiers

2018028

Identifier Type: -

Identifier Source: org_study_id