<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/NCT03011125</url>
  </required_header>
  <id_info>
    <org_study_id>ASKC263-LC-1</org_study_id>
    <nct_id>NCT03011125</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Evaluate the Safety and Tolerability of Dexlansoprazole Injection in Healthy Chinese Adults (Part 1)</brief_title>
  <official_title>A Phase 1 Double-blind, Dose-escalation, Placebo-controlled Tolerance Study in Healthy Chinese Adults After Single Intravenous Administration of Dexlansoprazole</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jiangsu Aosaikang Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase&#xD;
      1 clinical trial. This study will determine the safety and side-effect profile of an&#xD;
      investigational dexlansoprazole injection after single intravenous administration in healthy&#xD;
      Chinese adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single center, double-blind, dose-escalation, placebo-controlled clinical trial.&#xD;
      Dose escalation will be proceeded according to 3+3 design in five predefined dosing groups.&#xD;
      After completion of the 90mg dosing study, dose-escalation will be stopped, even though MTD&#xD;
      is not be observed. A total of 28 participants is scheduled to be recruited. The whole&#xD;
      follow-up period for each participant will be 3 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">March 9, 2017</completion_date>
  <primary_completion_date type="Actual">March 9, 2017</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>3 days</time_frame>
    <description>Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">28</enrollment>
  <condition>Safety Issues</condition>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexlansoprazole Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexlansoprazole injection</intervention_name>
    <arm_group_label>Dexlansoprazole Injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 Years;&#xD;
&#xD;
          -  Male (weight ≥50kg) or female (weight ≥45kg);&#xD;
&#xD;
          -  BMI between 19~28 kg/m2;&#xD;
&#xD;
          -  Healthy subjects (at screening);&#xD;
&#xD;
          -  Subject who totally understand the aim and progress of this clinical trial, make&#xD;
             decision by his/her free will, and signed a consent form to follow the progress.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy/hypersensitivity (including drug allergy) which is deemed relevant to the&#xD;
             trial as judged by the investigator;&#xD;
&#xD;
          -  Subject who has past or present history of any serious diseases, including (but not&#xD;
             limited to) digestive, cardiovascular, respiratory, urinary, musculoskeletal,&#xD;
             endocrine, psychiatric or neurological, hematologic, immunological or metabolic&#xD;
             disorders;&#xD;
&#xD;
          -  Medical examination, laboratory tests or ECG judged by the investigator to differ&#xD;
             significantly from normal clinical values;&#xD;
&#xD;
          -  HIV, HBV, or syphilis positive;&#xD;
&#xD;
          -  Drug dependency or abuse;&#xD;
&#xD;
          -  Heavy smokers (&gt;5 cigarettes per day);&#xD;
&#xD;
          -  Alcohol use;&#xD;
&#xD;
          -  Participation in another study with an investigational drug within the last 3 months&#xD;
             preceding this study;&#xD;
&#xD;
          -  Blood donation within the last 2 months (&gt;= 400 ml), or have a plan to donate blood&#xD;
             within 1 month after this study;&#xD;
&#xD;
          -  Intake of any other drug which might influence the results of the trial during two&#xD;
             weeks previous to the start of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lihua Wu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Zhejiang University</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>March 15, 2017</last_update_submitted>
  <last_update_submitted_qc>March 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexlansoprazole</mesh_term>
    <mesh_term>Lansoprazole</mesh_term>
  </intervention_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/NCT03011125
org study id: ASKC263-LC-1
nct id: NCT03011125
lead sponsor: 
collaborator: 
has dmc: No
This is a single center, randomized, double-blind, dose-escalation, placebo-controlled phase
      1 clinical trial. This study will determine the safety and side-effect profile of an
      investigational dexlansoprazole injection after single intravenous administration in healthy
      Chinese adults.
This is a single center, double-blind, dose-escalation, placebo-controlled clinical trial.
      Dose escalation will be proceeded according to 3+3 design in five predefined dosing groups.
      After completion of the 90mg dosing study, dose-escalation will be stopped, even though MTD
      is not be observed. A total of 28 participants is scheduled to be recruited. The whole
      follow-up period for each participant will be 3 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 3 days
description: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
arm group label: placebo
arm group type: Placebo Comparator
arm group label: Dexlansoprazole Injection
arm group type: Experimental
intervention type: Drug
intervention name: dexlansoprazole injection
arm group label: Dexlansoprazole Injection
intervention type: Other
intervention name: placebo
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lihua Wu, Doctor
role: Principal Investigator
affiliation: First Affiliated Hospital of Zhejiang University
responsible party type: Sponsor
mesh term: Dexlansoprazole
mesh term: Lansoprazole
sharing ipd: No