<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/NCT02219971</url>
  </required_header>
  <id_info>
    <org_study_id>HR-KB101</org_study_id>
    <secondary_id>ChiCTR-TRC-14005111</secondary_id>
    <nct_id>NCT02219971</nct_id>
  </id_info>
  <brief_title>Phase I Study of Kukoamine B Mesilate in Healthy Volunteers</brief_title>
  <official_title>Randomized, Double-blind Placebo-controlled Phase I Study to Assess Safety, Tolerance and Pharmacokinetics of a Single Intravenous Injection Kukoamine B Mesilate in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Chasesun Pharmaceutical Co., LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Southwest Hospital, China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Tianjin Chasesun Pharmaceutical Co., LTD</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single&#xD;
      intravenous injection Kukoamine B Mesilate in health volunteer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">May 6, 2015</completion_date>
  <primary_completion_date type="Actual">May 6, 2015</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events.</measure>
    <time_frame>7 days</time_frame>
    <description>AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters (t1/2,AUC0-inf,AUClast and Cmax;Fe0-48h(%),CLr24h)</measure>
    <time_frame>48h</time_frame>
    <description>Blood:（Pre Test）0,20min,40min after initiation of drug administration and 0,10min,20min,30min,45min,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h,24h after the end of administration;(Formal Test) 0,20min,40min after initiation of drug administration and 0,30min,1h,2h,3h,4h,6h,8h,12h,16h,24h after the end of administration; Urine:(Pre Test) 0,0-4h,4-8h,8-12h,12-24h,24-48h after initiation of drug administration;(Formal Test) 0,0-5h,5-9h,9-13h,13-25h,25-49h after initiation of drug administration .</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Kukoamine B Mesilate 0.005mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pre-test,open study: Kukoamine B Mesilate 0.005mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kukoamine B Mesilate 0.02mg/kg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose Escalation: Kukoamine B Mesilate 0.02mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.&#xD;
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kukoamine B Mesilate 0.04mg/kg +Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose Escalation: Kukoamine B Mesilate 0.04mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.&#xD;
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kukoamine B Mesilate 0.08mg/kg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose Escalation: Kukoamine B Mesilate 0.08mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.&#xD;
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kukoamine B Mesilate 0.12mg/kg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose Escalation: Kukoamine B Mesilate 0.12mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.&#xD;
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kukoamine B Mesilate 0.24mg/kg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose Escalation: Kukoamine B Mesilate 0.24mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.&#xD;
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Kukoamine B Mesilate 0.48mg/kg + Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dose Escalation: Kukoamine B Mesilate 0.48mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.&#xD;
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kukoamine B Mesilate</intervention_name>
    <description>Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.</description>
    <arm_group_label>Kukoamine B Mesilate 0.005mg/kg</arm_group_label>
    <arm_group_label>Kukoamine B Mesilate 0.02mg/kg + Placebo</arm_group_label>
    <arm_group_label>Kukoamine B Mesilate 0.04mg/kg +Placebo</arm_group_label>
    <arm_group_label>Kukoamine B Mesilate 0.08mg/kg + Placebo</arm_group_label>
    <arm_group_label>Kukoamine B Mesilate 0.12mg/kg + Placebo</arm_group_label>
    <arm_group_label>Kukoamine B Mesilate 0.24mg/kg + Placebo</arm_group_label>
    <arm_group_label>Kukoamine B Mesilate 0.48mg/kg + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gender: male or female, each sex ratio does not exceed 2/3;&#xD;
&#xD;
          -  18-45 years (including upper and lower limit), the general situation is good;&#xD;
&#xD;
          -  Body mass index (BMI) in 19-28 (including upper and lower limit of the range), BW ≥&#xD;
             50kg (female) and 60kg (male);&#xD;
&#xD;
          -  Nearly half of the year, no child care program and agreed to take effective measures&#xD;
             to contraception during the study period, women of childbearing age blood pregnancy&#xD;
             test was negative;&#xD;
&#xD;
          -  Subjects to fully understand the purpose, properties, method and reactions may occur&#xD;
             of test drug trials.Voluntarily signed the informed consents, and agreed to abide by&#xD;
             the requirements of clinical protocols.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary disease in important organs;&#xD;
&#xD;
          -  Mental or physical disability;&#xD;
&#xD;
          -  Familial hereditary disease;&#xD;
&#xD;
          -  Screening supine blood pressure (after 5 minutes of rest) systolic or diastolic blood&#xD;
             pressure greater than 90~140mmHg, beyond the scope of 50~90mmHg, Or pulse (HR) beyond&#xD;
             50bpm~100bpm&#xD;
&#xD;
          -  Abnormal results of any clinically meaningful physical examination, vital signs, ECG&#xD;
             or clinical laboratory;&#xD;
&#xD;
          -  History of immunodeficiency diseases, including HIV antibody positive;&#xD;
&#xD;
          -  Detection of antibody positive, hepatitis B surface antigen or antibody to hepatitis C&#xD;
             / syphilis positive;&#xD;
&#xD;
          -  Alcohol and drug abusers;&#xD;
&#xD;
          -  Smoking and drinking are (drinking 14 units of alcohol per week: 1 unit = beer 285 ml,&#xD;
             or liquor 25 ml, or wine 1 cup. numbers of daily smoking ≥ 5) and / or not smoking and&#xD;
             drinking in the test period;&#xD;
&#xD;
          -  Any discharge period may affect the study drug, or in the past 3 months participated&#xD;
             in any drug clinical trials;&#xD;
&#xD;
          -  Before entering the group 4 weeks using any prescription drugs before entering the&#xD;
             group, or use of any non prescription drugs within 2 weeks (vitamins, herbal tonics,&#xD;
             food additives), or into the group within 2 weeks before taking effect of drug&#xD;
             metabolizing enzymes in food, such as grapefruit or grapefruit drink. Can the use of&#xD;
             acetaminophen, but must record report in CRF;&#xD;
&#xD;
          -  The last 3 months had a history of blood donation or significant blood loss (more than&#xD;
             400ml);&#xD;
&#xD;
          -  There are drugs, the clinical significance of the history of food allergy and atopic&#xD;
             allergic diseases (asthma, urticaria, eczema dermatitis) or a known drug to test drugs&#xD;
             or similar drug allergy test;&#xD;
&#xD;
          -  Lactating women, pregnant women or unable to take effective contraceptive measures;&#xD;
&#xD;
          -  Researchers believe that the other is not suitable to take the test factors&#xD;
             participants.&#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_official>
    <last_name>SHUAI CHEN</last_name>
    <role>Study Director</role>
    <affiliation>TIAN JIN CHASE SUN PHARMACEUTICAL CO.,LTD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>May 2, 2017</last_update_submitted>
  <last_update_submitted_qc>May 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <!-- 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/NCT02219971
org study id: HR-KB101
secondary id: ChiCTR-TRC-14005111
nct id: NCT02219971
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess safety, tolerance and pharmacokinetics of a single
      intravenous injection Kukoamine B Mesilate in health volunteer
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Incidence of adverse events.
time frame: 7 days
description: AE,physical examination,monitoring of vital signs, Laboratory examination,ECG etc.
measure: Pharmacokinetic parameters (t1/2,AUC0-inf,AUClast and Cmax;Fe0-48h(%),CLr24h)
time frame: 48h
description: Blood:（Pre Test）0,20min,40min after initiation of drug administration and 0,10min,20min,30min,45min,1h,1.5h,2h,2.5h,3h,4h,6h,8h,12h,24h after the end of administration;(Formal Test) 0,20min,40min after initiation of drug administration and 0,30min,1h,2h,3h,4h,6h,8h,12h,16h,24h after the end of administration; Urine:(Pre Test) 0,0-4h,4-8h,8-12h,12-24h,24-48h after initiation of drug administration;(Formal Test) 0,0-5h,5-9h,9-13h,13-25h,25-49h after initiation of drug administration .
arm group label: Kukoamine B Mesilate 0.005mg/kg
arm group type: Experimental
description: Pre-test,open study: Kukoamine B Mesilate 0.005mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
arm group label: Kukoamine B Mesilate 0.02mg/kg + Placebo
arm group type: Experimental
description: Dose Escalation: Kukoamine B Mesilate 0.02mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
arm group label: Kukoamine B Mesilate 0.04mg/kg +Placebo
arm group type: Experimental
description: Dose Escalation: Kukoamine B Mesilate 0.04mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
arm group label: Kukoamine B Mesilate 0.08mg/kg + Placebo
arm group type: Experimental
description: Dose Escalation: Kukoamine B Mesilate 0.08mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
arm group label: Kukoamine B Mesilate 0.12mg/kg + Placebo
arm group type: Experimental
description: Dose Escalation: Kukoamine B Mesilate 0.12mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
arm group label: Kukoamine B Mesilate 0.24mg/kg + Placebo
arm group type: Experimental
description: Dose Escalation: Kukoamine B Mesilate 0.24mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
arm group label: Kukoamine B Mesilate 0.48mg/kg + Placebo
arm group type: Experimental
description: Dose Escalation: Kukoamine B Mesilate 0.48mg/kg single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
Placebo: single and intravenous(IV) drip for 1 hour in healthy volunteers.
intervention type: Drug
intervention name: Kukoamine B Mesilate
description: Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
arm group label: Kukoamine B Mesilate 0.005mg/kg
arm group label: Kukoamine B Mesilate 0.02mg/kg + Placebo
arm group label: Kukoamine B Mesilate 0.04mg/kg +Placebo
arm group label: Kukoamine B Mesilate 0.08mg/kg + Placebo
arm group label: Kukoamine B Mesilate 0.12mg/kg + Placebo
arm group label: Kukoamine B Mesilate 0.24mg/kg + Placebo
arm group label: Kukoamine B Mesilate 0.48mg/kg + Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: SHUAI CHEN
role: Study Director
affiliation: TIAN JIN CHASE SUN PHARMACEUTICAL CO.,LTD
facility: 
country: China
responsible party type: Sponsor