<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03791125</url>
  </required_header>
  <id_info>
    <org_study_id>2018028</org_study_id>
    <nct_id>NCT03791125</nct_id>
  </id_info>
  <brief_title>Phase I Single-dose Escalation Clinical Trial of Salvianolic Acid A Tablets</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University First Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shandong Huizhi Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Salvianolic acid A has a variety of pharmacological effects, such as: anti-oxidation,&#xD;
      scavenging oxygen free radicals, anti-fibrosis, anti-myocardial ischemia, anti-coagulation,&#xD;
      anti-thrombosis, anti-tumor, etc. Professor Du Guanhua, at Institue of Materia Medica,&#xD;
      Chinese Academy of Medical Sciences, first discovered that salvianolic acid A can alleviate&#xD;
      diabetic complications and improve patients' quality of life. With the support of major&#xD;
      national science and technology projects, the preclinical research work of salvianolic acid A&#xD;
      was completed, and the application was approved by the State Food and Drug Administration&#xD;
      (Clinical Approval No.: 2016L06293). Peking University First Hospital was used as the&#xD;
      research unit. This study is the first human clinical trial of the drug. The project leader&#xD;
      of this study is Professor Cui Yimin from Peking University First Hospital. The sponsor of&#xD;
      this project is Shandong Huizhi Pharmaceutical Technology Co., Ltd.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Anticipated">May 20, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 20, 2019</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Subject incidence of treatment-emergent adverse events</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with change from baseline in vital signs</measure>
    <time_frame>7 days</time_frame>
    <description>Heart rate, Blood Pressure，auxillary temperature</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in electrocardiograms (ECGs)</measure>
    <time_frame>7 days</time_frame>
    <description>PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of participants with change from baseline in clinical laboratory parameters</measure>
    <time_frame>7 days</time_frame>
    <description>blood routine, urine routine, biochemical parameters of blood and urine，coagulation tests</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile of Salvianolic acid A following administration of multiple doses assessed by area under the curve [AUC]</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax]</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax]</measure>
    <time_frame>2 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Neuropathy of Diabetes</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Salvianolic Acid A</intervention_name>
    <description>4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Oral Tablet</intervention_name>
    <description>Placebo tablets containing no salvianolic acid A will be given to healthy subjects.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) Gender: male or female, healthy volunteers; 2) Age: 18~45 years old; 3) Weight:&#xD;
             Male subjects need to weigh ≥ 50kg, female subjects should have ≥ 45kg, body mass&#xD;
             index [BMI = weight (kg) / height 2 (m2)] in the range of 19 ~ 25 kg / m2; 4) Subjects&#xD;
             must give informed consent to the trial prior to the trial and voluntarily sign a&#xD;
             written informed consent form; 5) The subject is able to communicate well with the&#xD;
             investigator and is able to complete the trial in accordance with the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  (1) Hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus and&#xD;
             syphilis positive; (2) alcoholics; (3) subjects who took any drug or long-term use of&#xD;
             drugs within 2 weeks before screening (4) Blood donors within 3 months prior to the&#xD;
             trial; (5) participated in any drug clinical trial within 3 months prior to screening;&#xD;
             (6) had a clear history of allergic disease; (7) had central nervous system,&#xD;
             cardiovascular Systematic, kidney, liver, digestive tract, lung disease, metabolic and&#xD;
             skeletal muscle system with a clear history or other significant disease; (8)&#xD;
             pregnant, lactating women; (9) other factors not suitable for participation in the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Xiaocong Pang, Ph.D.</last_name>
    <phone>010-66110802</phone>
    <email>pangxiaocong1227@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Pharmacy, Base for Clinical Trial, Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaocong Pang, Ph.D.</last_name>
      <phone>010-66110802</phone>
      <email>pangxiaocong1227@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>November 15, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>December 28, 2018</last_update_submitted>
  <last_update_submitted_qc>December 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 2, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Cui Yimin</investigator_full_name>
    <investigator_title>Director of Pharmacy, M.D. and Ph.D.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Salvianolic acid A</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03791125
org study id: 2018028
nct id: NCT03791125
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Subject incidence of treatment-emergent adverse events
time frame: 7 days
measure: Percentage of participants with change from baseline in vital signs
time frame: 7 days
description: Heart rate, Blood Pressure，auxillary temperature
measure: Change from baseline in electrocardiograms (ECGs)
time frame: 7 days
description: PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities
measure: Percentage of participants with change from baseline in clinical laboratory parameters
time frame: 7 days
description: blood routine, urine routine, biochemical parameters of blood and urine，coagulation tests
measure: PK profile of Salvianolic acid A following administration of multiple doses assessed by area under the curve [AUC]
time frame: 2 days
measure: PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax]
time frame: 2 days
measure: PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax]
time frame: 2 days
arm group label: Experimental
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Salvianolic Acid A
description: 4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study.
arm group label: Experimental
intervention type: Drug
intervention name: Placebo Oral Tablet
description: Placebo tablets containing no salvianolic acid A will be given to healthy subjects.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Xiaocong Pang, Ph.D.
phone: 010-66110802
email: pangxiaocong1227@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Cui Yimin
investigator title: Director of Pharmacy, M.D. and Ph.D.
mesh term: Salvianolic acid A