<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/NCT03811678</url>
  </required_header>
  <id_info>
    <org_study_id>PCD-DHEC84048-17-01</org_study_id>
    <nct_id>NCT03811678</nct_id>
  </id_info>
  <brief_title>The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult Subjects</brief_title>
  <official_title>A Phase I, Single-center, Randomized，Double-blind, Placebo-controlled, Single &amp; Multiple Ascending Dose Study to Assess the Tolerability and Pharmacokinetics of Kangdaprevir Sodium Tablet in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunshine Lake Pharma Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunshine Lake Pharma Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult&#xD;
      Subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single &amp; Multiple&#xD;
      Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium&#xD;
      Tablet in Healthy Adult Subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2018</start_date>
  <completion_date type="Actual">May 29, 2018</completion_date>
  <primary_completion_date type="Actual">May 29, 2018</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Baseline to day 13</time_frame>
    <description>To assess the tolerability after a single and multiple dose of HEC84048</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cmax</measure>
    <time_frame>predose to 72 hour after dosing</time_frame>
    <description>Maximum observed plasma concentration of HEC84048</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tmax</measure>
    <time_frame>predose to 72 hour after dosing</time_frame>
    <description>Time of the maximum observed plasma concentration of HEC84048</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AUC</measure>
    <time_frame>predose to 72 hour after dosing</time_frame>
    <description>Area under the plasma concentration-time curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>T1/2</measure>
    <time_frame>predose to 72 hour after dosing</time_frame>
    <description>Terminal elimination half-life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vz/F</measure>
    <time_frame>predose to 72 hour after dosing</time_frame>
    <description>Apparent volume of distribution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CL/F</measure>
    <time_frame>predose to 72 hour after dosing</time_frame>
    <description>Oral clearance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRT</measure>
    <time_frame>predose to 72 hour after dosing</time_frame>
    <description>Mean Residence Time</description>
  </primary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Chronic Hepatitis c</condition>
  <arm_group>
    <arm_group_label>50 mg single dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 mg single dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg single dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>400 mg single dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>600 mg single dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>800 mg single dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>100 mg multiple dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>200 mg multiple dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>400 mg multiple dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kangdaprevir Sodium Tablet</intervention_name>
    <description>Tablet，administered orally once daily</description>
    <arm_group_label>100 mg multiple dose</arm_group_label>
    <arm_group_label>100 mg single dose</arm_group_label>
    <arm_group_label>200 mg multiple dose</arm_group_label>
    <arm_group_label>200 mg single dose</arm_group_label>
    <arm_group_label>400 mg multiple dose</arm_group_label>
    <arm_group_label>400 mg single dose</arm_group_label>
    <arm_group_label>50 mg single dose</arm_group_label>
    <arm_group_label>600 mg single dose</arm_group_label>
    <arm_group_label>800 mg single dose</arm_group_label>
    <other_name>HEC84048Na</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Tablet，administered orally once daily</description>
    <arm_group_label>100 mg multiple dose</arm_group_label>
    <arm_group_label>100 mg single dose</arm_group_label>
    <arm_group_label>200 mg multiple dose</arm_group_label>
    <arm_group_label>200 mg single dose</arm_group_label>
    <arm_group_label>400 mg multiple dose</arm_group_label>
    <arm_group_label>400 mg single dose</arm_group_label>
    <arm_group_label>50 mg single dose</arm_group_label>
    <arm_group_label>600 mg single dose</arm_group_label>
    <arm_group_label>800 mg single dose</arm_group_label>
    <other_name>HEC84048Na matching placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to comprehend and sign the ICF voluntarily prior to initiate the study;&#xD;
&#xD;
          -  Able to complete the study according to the protocol;&#xD;
&#xD;
          -  Between 18 and 45 years of age（18 and 45 are inclusive）;&#xD;
&#xD;
          -  Body weight of male and female subject should be ≥50 kg and ≥45 kg respectively; Body&#xD;
             Mass Index (BMI) is between 18 and 28 kg/m2（18 and 28 are inclusive）;&#xD;
&#xD;
          -  Physical examination and vital signs without clinically significant abnormalities.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers, who smoke more than 5 cigarettes/day within 3 months before the study;&#xD;
&#xD;
          -  Drink frequently, namely alcohol consumption are 14 units per week (1 unit = 285 mL of&#xD;
             beer, or 25 mL of strong wine, or 100 mL of grape wine);&#xD;
&#xD;
          -  Donated blood or massive blood loss within 3 months before screening (&gt;450 mL）;&#xD;
&#xD;
          -  Have any disease that increases the risk of bleeding, such as acne, acute gastritis or&#xD;
             stomach and duodenal ulcers;&#xD;
&#xD;
          -  Have take any drug that changes liver enzyme activity within 1 month before taking the&#xD;
             study drug&#xD;
&#xD;
          -  Have taken any prescription drug, over-the-counter drug, vitamin product or herbal&#xD;
             medicine within 14 days prior to screening;&#xD;
&#xD;
          -  Have participated in any clinical trial or taken any study drug within 3 months before&#xD;
             dosing;&#xD;
&#xD;
          -  Viral hepatitis（including CHB and CHC）and positive test result of anti-HIV Ab or&#xD;
             syphilis.&#xD;
&#xD;
          -  Have taken any alcoholic products within 24 hours prior to taking the study drug&#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>Ding Yanhua, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>the First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>March 17, 2020</last_update_submitted>
  <last_update_submitted_qc>March 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03811678
org study id: PCD-DHEC84048-17-01
nct id: NCT03811678
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Tolerability and Pharmacokinetics Study of Kangdaprevir Sodium Tablet in Healthy Adult
      Subjects.
A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single & Multiple
      Ascending Dose Study to Access the Tolerability and Pharmacokinetics of Kangdaprevir Sodium
      Tablet in Healthy Adult Subjects.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse events
time frame: Baseline to day 13
description: To assess the tolerability after a single and multiple dose of HEC84048
measure: Cmax
time frame: predose to 72 hour after dosing
description: Maximum observed plasma concentration of HEC84048
measure: Tmax
time frame: predose to 72 hour after dosing
description: Time of the maximum observed plasma concentration of HEC84048
measure: AUC
time frame: predose to 72 hour after dosing
description: Area under the plasma concentration-time curve (AUC)
measure: T1/2
time frame: predose to 72 hour after dosing
description: Terminal elimination half-life
measure: Vz/F
time frame: predose to 72 hour after dosing
description: Apparent volume of distribution
measure: CL/F
time frame: predose to 72 hour after dosing
description: Oral clearance
measure: MRT
time frame: predose to 72 hour after dosing
description: Mean Residence Time
arm group label: 50 mg single dose
arm group type: Experimental
description: It includes two groups, one group is a pilot study, 2 healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet . Another group is a formal study, healthy subjects receive a single dose of 50 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
arm group label: 100 mg single dose
arm group type: Experimental
description: Healthy subjects, receiving a single dose of 100 mg Kangdaprevir Sodium Tablet (N=20) or matching placebo (N=2) under fed or fasted conditions, this group is a two-sequence, two-period crossover study.
arm group label: 200 mg single dose
arm group type: Experimental
description: Healthy subjects, receiving a single dose of 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
arm group label: 400 mg single dose
arm group type: Experimental
description: Healthy subjects, receiving a single dose of 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
arm group label: 600 mg single dose
arm group type: Experimental
description: Healthy subjects, receiving a single dose of 600 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
arm group label: 800 mg single dose
arm group type: Experimental
description: Healthy subjects, receiving a single dose of 800 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo (N=2).
arm group label: 100 mg multiple dose
arm group type: Experimental
description: Healthy subjects, receiving 100 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
arm group label: 200 mg multiple dose
arm group type: Experimental
description: Healthy subjects, receiving 200 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
arm group label: 400 mg multiple dose
arm group type: Experimental
description: Healthy subjects, receiving 400 mg Kangdaprevir Sodium Tablet (N=10) or matching placebo(N=2) once daily (q.d.) for 5 days.
intervention type: Drug
intervention name: Kangdaprevir Sodium Tablet
description: Tablet，administered orally once daily
arm group label: 100 mg multiple dose
arm group label: 100 mg single dose
arm group label: 200 mg multiple dose
arm group label: 200 mg single dose
arm group label: 400 mg multiple dose
arm group label: 400 mg single dose
arm group label: 50 mg single dose
arm group label: 600 mg single dose
arm group label: 800 mg single dose
other name: HEC84048Na
intervention type: Drug
intervention name: placebo
description: Tablet，administered orally once daily
arm group label: 100 mg multiple dose
arm group label: 100 mg single dose
arm group label: 200 mg multiple dose
arm group label: 200 mg single dose
arm group label: 400 mg multiple dose
arm group label: 400 mg single dose
arm group label: 50 mg single dose
arm group label: 600 mg single dose
arm group label: 800 mg single dose
other name: HEC84048Na matching placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ding Yanhua, Doctor
role: Principal Investigator
affiliation: The First Hospital of Jilin University
facility: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
sharing ipd: No