<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/NCT02209987</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-326-1430</org_study_id>
    <nct_id>NCT02209987</nct_id>
  </id_info>
  <brief_title>Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults</brief_title>
  <official_title>A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will estimate the absolute bioavailability of subcutaneously injected GS-5745,&#xD;
      characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after&#xD;
      subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation&#xD;
      of anti-GS-5745 antibodies after SC and IV administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PK profile of GS-5745</measure>
    <time_frame>Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8</time_frame>
    <description>This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable:&#xD;
Cmax: maximum observed concentration of drug in plasma&#xD;
AUClast: concentration of drug from time zero to the last quantifiable concentration&#xD;
AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidences of adverse events and laboratory abnormalities</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>This composite endpoint will measure the safety and tolerability profile of GS-5745.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>GS-5745 SC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single dose of GS-5745 by SC injection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GS-5745 IV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single dose of GS-5745 by IV infusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GS-5745 SC</intervention_name>
    <description>GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe</description>
    <arm_group_label>GS-5745 SC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GS-5745 IV</intervention_name>
    <description>GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials</description>
    <arm_group_label>GS-5745 IV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In the opinion of the investigator, individuals must be in good general health based&#xD;
             upon medical history and physical examination&#xD;
&#xD;
          -  Females, of childbearing potential, and males must agree to utilize protocol specific&#xD;
             contraception methods&#xD;
&#xD;
          -  Screening laboratory evaluations must be within defined thresholds&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human&#xD;
             immunodeficiency virus (HIV)&#xD;
&#xD;
          -  Pregnant and lactating females&#xD;
&#xD;
          -  History of clinically significant illness (including psychiatric or cardiac) or any&#xD;
             other medical disorder that may interfere with individual treatment and/or adherence&#xD;
             to the protocol&#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>Bittoo Kanwar, MD</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>New Zealand</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>October 23, 2014</last_update_submitted>
  <last_update_submitted_qc>October 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2014</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>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antibodies, Monoclonal</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/NCT02209987
org study id: GS-US-326-1430
nct id: NCT02209987
lead sponsor: 
has dmc: No
This study will estimate the absolute bioavailability of subcutaneously injected GS-5745,
      characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after
      subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation
      of anti-GS-5745 antibodies after SC and IV administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PK profile of GS-5745
time frame: Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8
description: This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable:
Cmax: maximum observed concentration of drug in plasma
AUClast: concentration of drug from time zero to the last quantifiable concentration
AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity
measure: Incidences of adverse events and laboratory abnormalities
time frame: Up to 8 weeks
description: This composite endpoint will measure the safety and tolerability profile of GS-5745.
arm group label: GS-5745 SC
arm group type: Experimental
description: Participants will receive a single dose of GS-5745 by SC injection.
arm group label: GS-5745 IV
arm group type: Experimental
description: Participants will receive a single dose of GS-5745 by IV infusion.
intervention type: Drug
intervention name: GS-5745 SC
description: GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe
arm group label: GS-5745 SC
intervention type: Drug
intervention name: GS-5745 IV
description: GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials
arm group label: GS-5745 IV
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bittoo Kanwar, MD
role: Study Director
affiliation: Gilead Sciences
facility: 
country: New Zealand
responsible party type: Sponsor
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Antibodies, Monoclonal