<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/NCT02206867</url>
  </required_header>
  <id_info>
    <org_study_id>LG-ALCL001</org_study_id>
    <nct_id>NCT02206867</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics and Safety Study of LBAL in Healthy Subjects</brief_title>
  <official_title>A Randomized, Double-Blind, Parallel-Group Clinical Study to Compare Pharmacokinetics, Safety and Tolerability of LBAL 40 mg With Humira® 40 mg After a Single Subcutaneous Administration in Healthy Male Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LG Life Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LG Life Sciences</source>
  <brief_summary>
    <textblock>
      To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those&#xD;
      of Humira®.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity</measure>
    <time_frame>0 to 65 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum measured concentration of the analyte in serum</measure>
    <time_frame>0 to 65 days</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>LBAL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Developed by LG Life Sciences</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Humira®</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Abbvie</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>LBAL</intervention_name>
    <description>Anti-inflammatory agents</description>
    <arm_group_label>LBAL</arm_group_label>
    <other_name>Adalimumab</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Humira</intervention_name>
    <description>Anti-inflammatory agents</description>
    <arm_group_label>Humira®</arm_group_label>
    <other_name>Adalimumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 20-45 years old healthy males&#xD;
&#xD;
          2. Body mass index 19.0 ~ 28.0 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of current or latent tuberculosis (TB); history of severe active chronic or&#xD;
             local infection including TB&#xD;
&#xD;
          2. Severe infection (e.g. sepsis) requiring admission or antibiotics treatment within&#xD;
             four weeks prior to administration&#xD;
&#xD;
          3. Clinically relevant previous or concomitant disease including hepatic, renal,&#xD;
             neurological, respiratory, gastrointestinal, endocrine, hematologic, oncologic,&#xD;
             cardiovascular, urinary, musculoskeletal or psychiatric, autoimmune disease/disorders&#xD;
&#xD;
          4. Chronic or relevant acute infections. A negative result for human immunodeficiency&#xD;
             virus (HIV), Hepatitis B (Hep B), and hepatitis C (Hep C) is required for&#xD;
             participation (i.e. HIV Ab, HBsAg, HBcAb, HCV Ab)&#xD;
&#xD;
          5. Fever greater than 38.3℃ within a week prior to administration of study drug&#xD;
&#xD;
          6. Previous or current drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyung-Sang Yu, M.D., Ph.D., M.B.A</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital</affiliation>
  </overall_official>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>June 12, 2015</last_update_submitted>
  <last_update_submitted_qc>June 12, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 15, 2015</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>Adalimumab</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/NCT02206867
org study id: LG-ALCL001
nct id: NCT02206867
lead sponsor: 
To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those
      of Humira®.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity
time frame: 0 to 65 days
measure: Maximum measured concentration of the analyte in serum
time frame: 0 to 65 days
arm group label: LBAL
arm group type: Experimental
description: Developed by LG Life Sciences
arm group label: Humira®
arm group type: Active Comparator
description: Abbvie
intervention type: Biological
intervention name: LBAL
description: Anti-inflammatory agents
arm group label: LBAL
other name: Adalimumab
intervention type: Biological
intervention name: Humira
description: Anti-inflammatory agents
arm group label: Humira®
other name: Adalimumab
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kyung-Sang Yu, M.D., Ph.D., M.B.A
role: Principal Investigator
affiliation: Dep. of Clnical Pharmacology, Seoul National University College of Medicine and Hospital
responsible party type: Sponsor
mesh term: Adalimumab