<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/NCT03023787</url>
  </required_header>
  <id_info>
    <org_study_id>L47-Ib-01</org_study_id>
    <nct_id>NCT03023787</nct_id>
  </id_info>
  <brief_title>Study of Hepalatide(L47) at Phase Ib in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Double-Blinded, Safety and Pharmacokinetic Study of Escalating Single Doses of Hepalatide in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai HEP Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai HEP Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical&#xD;
      pharmacokinetics in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, double-blinded, dose escalating, phase Ib trial, which will be&#xD;
      conducted in No. 302 Hospital of China. There are three cohorts at dose of 4.2mg, 6.3mg and&#xD;
      8.4mg. All healthy volunteers will be randomized into Hepalatide or placebo group at 4:1&#xD;
      rate, all healthy volunteers will be received treatment drug by abdominal subcutaneous&#xD;
      injection once a day for seven days and will be observed for 3 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Healthy participants with treatment-related adverse events as assessed by &quot;guiding principle of grading standards for the adverse reactions in clinical trials of vaccine for prevention&quot; or CTCAE v4.0</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>half-time</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>apparent volume of distribution</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Hepatitis B， Chronic</condition>
  <arm_group>
    <arm_group_label>Hepalatide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hepalatide 4.2mg, 6.3mg and 8.4mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 4.2mg, 6.3mg and 8.4mg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hepalatide</intervention_name>
    <description>There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.</description>
    <arm_group_label>Hepalatide</arm_group_label>
    <other_name>treatment drug</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>control drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages between 18 and 45 years&#xD;
&#xD;
          -  BMI Index between 19 and 25 (BMI=weight/height2)&#xD;
&#xD;
          -  Normal previous history and physical exam&#xD;
&#xD;
          -  No drug and alcohol abuse&#xD;
&#xD;
          -  No illness in 4 weeks and no drug therapy in 2 weeks&#xD;
&#xD;
          -  No blood donation or subject not sampled in 3 months&#xD;
&#xD;
          -  Consistent and correct use of recommended methods of birth control for men and women&#xD;
&#xD;
          -  Good compliance with study protocol&#xD;
&#xD;
          -  Understand and agree to sign a consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection with HAV, HBV, HCV, HEV, HIV, EBV or CMV&#xD;
&#xD;
          -  Abnormal and clinical significance test of physical examination, vital signs, blood&#xD;
             routines, urine routines, liver and kidney functions, coagulation indicator,&#xD;
             electrolyte, glucose, blood lipid, thyroid functions, chest X-Ray, ECG, B ultrasound&#xD;
             of gallbladder, spleen and kidney, AFP ,and CEA&#xD;
&#xD;
          -  Positive for anti-Pre-S1 antibody&#xD;
&#xD;
          -  Women being pregnant or nursing, or with abnormal sex hormones, B ultrasound of&#xD;
             ovaries/uterus proliferative diseases or breast mass&#xD;
&#xD;
          -  Unable to quit smoking in trial&#xD;
&#xD;
          -  Subject with little chance of enrollment (i.e. the weak)&#xD;
&#xD;
          -  Subject not suitable to join the trial under other circumstances judged by&#xD;
             investigator.&#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>zhenman wei</last_name>
    <role>Principal Investigator</role>
    <affiliation>302 Military Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>302 Military Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 15, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</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 B</mesh_term>
    <mesh_term>Hepatitis B, 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/NCT03023787
org study id: L47-Ib-01
nct id: NCT03023787
lead sponsor: 
has dmc: Yes
To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical
      pharmacokinetics in healthy volunteers.
This is a randomized, double-blinded, dose escalating, phase Ib trial, which will be
      conducted in No. 302 Hospital of China. There are three cohorts at dose of 4.2mg, 6.3mg and
      8.4mg. All healthy volunteers will be randomized into Hepalatide or placebo group at 4:1
      rate, all healthy volunteers will be received treatment drug by abdominal subcutaneous
      injection once a day for seven days and will be observed for 3 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Healthy participants with treatment-related adverse events as assessed by "guiding principle of grading standards for the adverse reactions in clinical trials of vaccine for prevention" or CTCAE v4.0
time frame: 6 months
measure: Maximum Plasma Concentration (Cmax)
time frame: 6 months
measure: Area under the plasma concentration versus time curve (AUC)
time frame: 6 months
measure: half-time
time frame: 6 months
measure: apparent volume of distribution
time frame: 6 months
arm group label: Hepalatide
arm group type: Experimental
description: Hepalatide 4.2mg, 6.3mg and 8.4mg
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo 4.2mg, 6.3mg and 8.4mg
intervention type: Drug
intervention name: Hepalatide
description: There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.
arm group label: Hepalatide
other name: treatment drug
intervention type: Drug
intervention name: Placebo
description: There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.
arm group label: Placebo
other name: control drug
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: zhenman wei
role: Principal Investigator
affiliation: 302 Military Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
sharing ipd: No