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

Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Evaluation of Safety, Tolerability, and Pharmacokinetic Properties of Salvianolic Acid A Tablets in Healthy Volunteers

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.

Study Overview

• Status: Unknown
• Conditions: Neuropathy of Diabetes
• Intervention / Treatment: Drug: Salvianolic Acid A; Drug: Placebo Oral Tablet

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaocong Pang, Ph.D.; Phone Number: 010-66110802; Email: pangxiaocong1227@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Department of Pharmacy, Base for Clinical Trial, Peking University First Hospital
      • Contact: Xiaocong Pang, Ph.D.; Phone Number: 010-66110802; Email: pangxiaocong1227@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Oral Tablet; Placebo tablets containing no salvianolic acid A will be given to healthy subjects.
Experimental: Experimental	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Anticipated): March 20, 2019
• Study Completion (Anticipated): May 20, 2019

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: December 28, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 28, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Proton Pump Inhibitors; Salvianolic acid A
• Other Study ID Numbers: 2018028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No