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

NCT03791125 | Unknown Phase 1

• 1 other identifier: 2018028
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Subject incidence of treatment-emergent adverse events

  7 days

• Percentage of participants with change from baseline in vital signs

  Heart rate, Blood Pressure，auxillary temperature

  7 days

• Change from baseline in electrocardiograms (ECGs)

  PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities

  7 days

• Percentage of participants with change from baseline in clinical laboratory parameters

  blood routine, urine routine, biochemical parameters of blood and urine，coagulation tests

  7 days

• PK profile of Salvianolic acid A following administration of multiple doses assessed by area under the curve [AUC]

  2 days

• PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax]

  2 days

• PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax]

  2 days

Study Arms (2)

Experimental

EXPERIMENTAL

Drug: Salvianolic Acid A

Placebo

PLACEBO COMPARATOR

Drug: Placebo Oral Tablet

Interventions

Salvianolic Acid A DRUG

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

Experimental

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \) 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Shandong Huizhi Pharmaceutical Technology Co., Ltd.: collaborator
• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: collaborator

Study Sites (1)

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

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Interventions

salvianolic acid A

Central Study Contacts

Xiaocong Pang, Ph.D.

CONTACT

010-66110802; pangxiaocong1227@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pharmacy, M.D. and Ph.D.

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: January 2, 2019
• Study Start: November 20, 2018
• Primary Completion: March 20, 2019
• Study Completion: May 20, 2019
• Last Updated: January 2, 2019

Record last verified: 2018-12

Locations

CN (1)