Phase I Study of Continuous Administration of Salvianolic Acid A Tablet

Randomized, Double-blind, Placebo-controlled, Continuous Dosing, Single-center, 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).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.

Study Overview

• Status: Unknown
• Conditions: Diabetes
• Intervention / Treatment: Drug: salvianolic acid A; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Xiaocong Pang

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: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: Yimin Cui, Ph.D, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 8, 2019
• Primary Completion (ANTICIPATED): April 30, 2019
• Study Completion (ANTICIPATED): May 30, 2019

Study Registration Dates

• First Submitted: April 6, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

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: SAA003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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