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

NCT03791125 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-01-02

No results posted yet for this study

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

Interventions

DRUG

Salvianolic Acid A

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

DRUG

Placebo Oral Tablet

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

Sponsors & Collaborators

  • Shandong Huizhi Pharmaceutical Technology Co., Ltd.

    collaborator UNKNOWN

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2019-03-20
Completion
2019-05-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03791125 on ClinicalTrials.gov