<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/NCT03748940</url>
  </required_header>
  <id_info>
    <org_study_id>17097</org_study_id>
    <secondary_id>I9O-MC-AABC</secondary_id>
    <secondary_id>2018-000773-68</secondary_id>
    <nct_id>NCT03748940</nct_id>
  </id_info>
  <brief_title>Study of LY3074828 in Healthy Participants</brief_title>
  <official_title>A Study to Investigate the Tolerability of Subcutaneous Injections of LY3074828 Compared to Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate different concentrations and formulations of&#xD;
      LY3074828 compared to placebo (&quot;dummy drug&quot;).&#xD;
&#xD;
      The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days&#xD;
      prior to the start of each study part. For each participant in Part A and Part B, the total&#xD;
      duration of the clinical trial will be approximately 16 weeks, including screening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Actual">June 18, 2019</completion_date>
  <primary_completion_date type="Actual">June 18, 2019</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>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS) Pain Score</measure>
    <time_frame>Within 1-minute post injection</time_frame>
    <description>The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Part A: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered subcutaneously (SC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A: LY3074828</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3074828 administered SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: LY3074828</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY3074828 administered SC</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B: LY900021</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LY900021 (LY3074828 + LY9999QS) administered SC</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY3074828</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Part A: LY3074828</arm_group_label>
    <arm_group_label>Part B: LY3074828</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Part A: Placebo</arm_group_label>
    <arm_group_label>Part B: Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>LY900021</intervention_name>
    <description>Administered SC</description>
    <arm_group_label>Part B: LY900021</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Have venous access sufficient to allow for blood sampling and administration of&#xD;
        investigational product&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Must not have an average weekly alcohol intake that exceeds 28 units per week (males)&#xD;
             and 21 units per week (females)&#xD;
&#xD;
          -  Must not show evidence of active or latent tuberculosis (TB)&#xD;
&#xD;
          -  Must not have received live vaccine(s) (including attenuated live vaccines and those&#xD;
             administered intranasally) within 1 month of screening or intend to receive during the&#xD;
             study&#xD;
&#xD;
          -  Must not be immunocompromised&#xD;
&#xD;
          -  Must not have known hypersensitivity to hyaluronidases&#xD;
&#xD;
          -  Must not have received treatment with biologic agents (e.g. monoclonal antibodies,&#xD;
             including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior&#xD;
             to dosing&#xD;
&#xD;
          -  Must not have significant allergies to humanized monoclonal antibodies&#xD;
&#xD;
          -  Must not have clinically significant multiple or severe drug allergies, intolerance to&#xD;
             topical corticosteroids, or severe post treatment hypersensitivity reactions&#xD;
&#xD;
          -  Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except&#xD;
             for basal cell or squamous epithelial carcinomas of the skin that have been resected&#xD;
             with no evidence of metastatic disease for 3 years&#xD;
&#xD;
          -  Must not have had breast cancer within the past 10 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Clinical Research Ltd</name>
      <address>
        <city>Leeds</city>
        <state>West Yorkshire</state>
        <zip>LS2 9LH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>July 18, 2019</last_update_submitted>
  <last_update_submitted_qc>July 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2019</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>Mirikizumab</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/NCT03748940
org study id: 17097
secondary id: I9O-MC-AABC
secondary id: 2018-000773-68
nct id: NCT03748940
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate different concentrations and formulations of
      LY3074828 compared to placebo ("dummy drug").

      The study will consist of 2 parts: Part A and Part B. Screening is required within 28 days
      prior to the start of each study part. For each participant in Part A and Part B, the total
      duration of the clinical trial will be approximately 16 weeks, including screening.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Visual Analog Scale (VAS) Pain Score
time frame: Within 1-minute post injection
description: The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).
arm group label: Part A: Placebo
arm group type: Placebo Comparator
description: Placebo administered subcutaneously (SC)
arm group label: Part A: LY3074828
arm group type: Experimental
description: LY3074828 administered SC
arm group label: Part B: Placebo
arm group type: Placebo Comparator
description: Placebo administered SC
arm group label: Part B: LY3074828
arm group type: Experimental
description: LY3074828 administered SC
arm group label: Part B: LY900021
arm group type: Experimental
description: LY900021 (LY3074828 + LY9999QS) administered SC
intervention type: Drug
intervention name: LY3074828
description: Administered SC
arm group label: Part A: LY3074828
arm group label: Part B: LY3074828
intervention type: Drug
intervention name: Placebo
description: Administered SC
arm group label: Part A: Placebo
arm group label: Part B: Placebo
intervention type: Drug
intervention name: LY900021
description: Administered SC
arm group label: Part B: LY900021
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Mirikizumab
sharing ipd: No