Phase I Study of Continuous Administration of Salvianolic Acid A Tablet

NCT03908242 | Unknown Phase 1

• 1 other identifier: SAA003
• Study Type: interventional
• Target: 24
• 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).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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (5)

• Subject incidence of treatment-emergent adverse events

  10 or 11 days

• Percentage of participants with change from baseline in vital signs

  Heart rate, Blood Pressure，auxillary temperature

  10 or 11 days

• Change from baseline in electrocardiograms (ECGs)

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

  10 or 11 days

• 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

• Plasma concentrations of salvianolic acid A

  To investigate the pharmacokinetics (PK) profile of multiple ascending doses of salvianolic acid A

  8 days

Study Arms (2)

Salvianolic Acid A

EXPERIMENTAL

2 anticipated doses are 90 mg and 180 mg.

Drug: salvianolic acid A

Placebo Oral Tablet

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

salvianolic acid A DRUG

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

Salvianolic Acid A

Placebo DRUG

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

Placebo Oral Tablet

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

Study Sites (1)

Xiaocong Pang

Beijing, 100034, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

salvianolic acid A

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Yimin Cui, Ph.D

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaocong Pang, Ph.D

CONTACT

+861066110802; xiaocong.pang@pkufh.com

Nan Zhao, M.D

CONTACT

+861066110802; 790837037@qq.com

Study Design

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

Study Record Dates

• First Submitted: April 6, 2019
• First Posted: April 9, 2019
• Study Start: April 8, 2019
• Primary Completion: April 30, 2019
• Study Completion: May 30, 2019
• Last Updated: April 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)