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Phase I Study of Continuous Administration of Salvianolic Acid A Tablet

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908242
Recruitment Status : Unknown
Verified April 2019 by Cui Yimin, Peking University First Hospital.
Recruitment status was:  Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Cui Yimin, Peking University First Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Drug: salvianolic acid A Drug: Placebo Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Placebo-controlled, Continuous Dosing, Single-center, Evaluation of Safety, Tolerability, and Pharmacokinetic Properties of Salvianolic Acid A Tablets in Healthy Volunteers
Estimated Study Start Date : April 8, 2019
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Salvianolic Acid A
2 anticipated doses are 90 mg and 180 mg.
 Drug: salvianolic acid A
salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd
Placebo Comparator: Placebo Oral Tablet
Placebo tablets containing no salvianolic acid A will be given to healthy subjects.
 Drug: Placebo
salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd


Outcome Measures
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Primary Outcome Measures :
  1. Subject incidence of treatment-emergent adverse events [ Time Frame: 10 or 11 days ]
  2. Percentage of participants with change from baseline in vital signs [ Time Frame: 10 or 11 days ]
    Heart rate, Blood Pressure，auxillary temperature

  3. Change from baseline in electrocardiograms (ECGs) [ Time Frame: 10 or 11 days ]
    PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities

  4. Percentage of participants with change from baseline in clinical laboratory parameters [ Time Frame: 10 or 11 days ]
    blood routine, urine routine, biochemical parameters of blood and urine，coagulation tests

  5. Plasma concentrations of salvianolic acid A [ Time Frame: 8 days ]
    To investigate the pharmacokinetics (PK) profile of multiple ascending doses of salvianolic acid A


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908242


Contacts
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Contact: Xiaocong Pang, Ph.D +861066110802 xiaocong.pang@pkufh.com
Contact: Nan Zhao, M.D +861066110802 790837037@qq.com

Locations
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China
Xiaocong Pang
Beijing, China, 100034
Contact: Xiaocong Pang, Ph.D    +861066110802    xiaocong.pang@pkufh.com   
Sponsors and Collaborators
Peking University First Hospital
Investigators
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Principal Investigator: Yimin Cui, Ph.D Peking University First Hospital
More Information
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Responsible Party: Cui Yimin, Director of Pharmacy, M.D. and Ph.D., Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03908242    
Other Study ID Numbers: SAA003
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Salvianolic acid A
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Proton Pump Inhibitors