<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/NCT02235727</url>
  </required_header>
  <id_info>
    <org_study_id>GBR 900-101</org_study_id>
    <secondary_id>2013-005480-31</secondary_id>
    <nct_id>NCT02235727</nct_id>
  </id_info>
  <brief_title>Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects</brief_title>
  <official_title>A Phase 1, Double-Blind, Randomised, Placebo-Controlled, Study to Evaluate the Safety and Pharmacokinetics of GBR 900 in Adult Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glenmark Pharmaceuticals Ltd. India</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Glenmark Pharmaceuticals S.A.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Glenmark Pharmaceuticals Ltd. India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Single Dose Study of GBR 900 in Healthy Volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to&#xD;
      look at safety, how well the study drug is tolerated, how much of the study drug gets into&#xD;
      the blood stream, and how long it takes the body to get rid of it when given to humans.&#xD;
      Information about any side effects that may occur will also be collected. Each participant&#xD;
      will remain in the study for approximately 3.5 months. This study is for research purposes&#xD;
      only and is not intended to treat any medical condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 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>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Drug related adverse events (AEs) or any serious AEs</measure>
    <time_frame>71 days</time_frame>
    <description>All treatment - emergent adverse events (TEAEs), occuring during the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events in adult healthy volunteers from baseline to day 71.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers</measure>
    <time_frame>Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under Curve [(AUC (0-∞) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers</measure>
    <time_frame>Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Half life (t1/2) of single ascending doses of GBR 900 in adult healthy volunteers</measure>
    <time_frame>Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity of GBR 900</measure>
    <time_frame>Pre-dose and at day 29, day 43, and day 71</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>GBR 900</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test treatment GBR 900</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GBR 900</intervention_name>
    <arm_group_label>GBR 900</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be ≥ 50&#xD;
             kg.&#xD;
&#xD;
          2. Men and women aged between 18 and 55 years (inclusive). Female subjects must be of&#xD;
             non-child-bearing potential&#xD;
&#xD;
          3. Subjects who are otherwise healthy and free from clinically significant illness or&#xD;
             disease as determined by medical history, vital signs, physical examinations, and&#xD;
             other tests performed by the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects with a history of neuropathy or otherwise present with risk factors for&#xD;
             neurological toxicity like chronic alcoholism or clinically significant neurological&#xD;
             (e.g. dementia, cognitive decline, seizure disorders) or psychiatric disorders.&#xD;
&#xD;
          2. Subjects with a recent history of live vaccination within the past 3 month or presence&#xD;
             of active infections within the previous month.&#xD;
&#xD;
          3. Subjects with previous exposure to antibody therapies or administration of&#xD;
             immunoglobulins (Ig) within 6 months of randomization.&#xD;
&#xD;
          4. Subjects with a history of or presence of inflammatory disease or rheumatological&#xD;
             diseases or joint diseases including OA or any undiagnosed pain in joints.&#xD;
&#xD;
          5. Subjects with a current and/or recent history of arthralgia or a history of&#xD;
             fibromyalgia, migraine, neuralgia, or systemic painful conditions, or medical or&#xD;
             arthritic conditions or any undiagnosed pain or systemic inflammatory disorders.&#xD;
&#xD;
          6. Any evidence of organ dysfunction or any clinically significant deviation from the&#xD;
             normal in history, physical or neurological determinations or investigations or has a&#xD;
             clinical condition or receiving therapy that, in the opinion of the Investigator,&#xD;
             would make the subjects unsuitable for study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jim Bush, MBChB, PhD, MRCS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Covance</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Unit Ltd</name>
      <address>
        <city>Leeds</city>
        <state>Yorkshire</state>
        <zip>LS29LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>January 23, 2017</last_update_submitted>
  <last_update_submitted_qc>January 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02235727
org study id: GBR 900-101
secondary id: 2013-005480-31
nct id: NCT02235727
lead sponsor: 
collaborator: 
has dmc: No
A Single Dose Study of GBR 900 in Healthy Volunteers.
This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to
      look at safety, how well the study drug is tolerated, how much of the study drug gets into
      the blood stream, and how long it takes the body to get rid of it when given to humans.
      Information about any side effects that may occur will also be collected. Each participant
      will remain in the study for approximately 3.5 months. This study is for research purposes
      only and is not intended to treat any medical condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Drug related adverse events (AEs) or any serious AEs
time frame: 71 days
description: All treatment - emergent adverse events (TEAEs), occuring during the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events in adult healthy volunteers from baseline to day 71.
measure: Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers
time frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
measure: Area Under Curve [(AUC (0-∞) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers
time frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
measure: Half life (t1/2) of single ascending doses of GBR 900 in adult healthy volunteers
time frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
measure: Immunogenicity of GBR 900
time frame: Pre-dose and at day 29, day 43, and day 71
arm group label: GBR 900
arm group type: Experimental
description: Test treatment GBR 900
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo Treatment
intervention type: Drug
intervention name: GBR 900
arm group label: GBR 900
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jim Bush, MBChB, PhD, MRCS
role: Principal Investigator
affiliation: Covance
facility: 
country: United Kingdom
responsible party type: Sponsor