Clinical trial NCT03791125: Phase I Single-dose Escalation Clinical Trial of Salvianolic Acid A Tablets
Official title: Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Evaluation of Safety, Tolerability, and Pharmacokinetic Properties of Salvianolic Acid A Tablets in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Neuropathy of Diabetes
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Huizhi Pharmaceutical Technology Co., Ltd.
name: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
First posted: 2019-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Subject incidence of treatment-emergent adverse events
timeFrame: 7 days
measure: Percentage of participants with change from baseline in vital signs
timeFrame: 7 days
measure: Change from baseline in electrocardiograms (ECGs)
timeFrame: 7 days
measure: Percentage of participants with change from baseline in clinical laboratory parameters
timeFrame: 7 days
measure: PK profile of Salvianolic acid A following administration of multiple doses assessed by area under the curve [AUC]
timeFrame: 2 days
measure: PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax]
timeFrame: 2 days
measure: PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax]
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Pharmacy, Base for Clinical Trial, Peking University First Hospital
state: Beijing
Study officials:
References: