<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/NCT03267732</url>
  </required_header>
  <id_info>
    <org_study_id>17297</org_study_id>
    <secondary_id>J1L-AM-JZGE</secondary_id>
    <secondary_id>AM0010-801</secondary_id>
    <nct_id>NCT03267732</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Pharmacokinetics in Participants After Dosing With Pegilodecakin (LY3500518)</brief_title>
  <acronym>Willow 1</acronym>
  <official_title>A Phase 1 Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of AM0010 in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ARMO BioSciences</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy&#xD;
      participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics&#xD;
      in healthy adult participants after single and multiple subcutaneous injections of&#xD;
      pegilodecakin.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 5, 2017</start_date>
  <completion_date type="Actual">October 30, 2017</completion_date>
  <primary_completion_date type="Actual">October 30, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacokinetic parameters, Cmax</measure>
    <time_frame>43 days</time_frame>
    <description>maximal plasma concentration (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters, Tmax</measure>
    <time_frame>43 days</time_frame>
    <description>maximal concentration (Tmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters, AUC</measure>
    <time_frame>43 days</time_frame>
    <description>area under the plasma concentration curve (AUC)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetic parameters, CL/F</measure>
    <time_frame>43 days</time_frame>
    <description>clearance (CL/F).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)</measure>
    <time_frame>43 days</time_frame>
    <description>Evaluate the safety of single/multiple SQ doses of Pegilodecakin - Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, EKGs, and vital signs</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Healthy Adult Subjects</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pegilodecakin</intervention_name>
    <description>Pegilodecakin Alone</description>
    <arm_group_label>1</arm_group_label>
    <arm_group_label>2</arm_group_label>
    <other_name>LY3500518</other_name>
    <other_name>AM0010</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female between 18 and 55 years of age, inclusive&#xD;
&#xD;
          2. Must have a body mass index (BMI) between 19 and 32 (kg/m2) at study Screening&#xD;
&#xD;
          3. Must be HIV negative by HIV 1/0/2 testing&#xD;
&#xD;
          4. Must be Hepatitis B (HBV) surface antigen negative&#xD;
&#xD;
          5. Must be Hepatitis C (HCV) antibody negative&#xD;
&#xD;
          6. Females must have a negative serum pregnancy test&#xD;
&#xD;
          7. Must refrain from blood donation from 30 days prior to Day 0 through completion of the&#xD;
             study and continuing for at least 30 days from date of last dose of study drug&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating subjects&#xD;
&#xD;
          2. Have previously participated in an investigational trial involving administration of&#xD;
             any investigational compound within 30 days prior to the study dosing&#xD;
&#xD;
          3. Have poor venous access and are unable to donate blood&#xD;
&#xD;
          4. Have been vaccinated within 90 days of study dosing&#xD;
&#xD;
          5. Current alcohol or substance abuse judged by the Investigator to interfere with&#xD;
             subject compliance&#xD;
&#xD;
          6. Have history of significant drug sensitivity or drug allergy.&#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>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>PPD Development</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03267732
org study id: 17297
secondary id: J1L-AM-JZGE
secondary id: AM0010-801
nct id: NCT03267732
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy
      participants.
This is an open-label, single-center, phase 1 study designed to evaluate the pharmacokinetics
      in healthy adult participants after single and multiple subcutaneous injections of
      pegilodecakin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Pharmacokinetic parameters, Cmax
time frame: 43 days
description: maximal plasma concentration (Cmax)
measure: Pharmacokinetic parameters, Tmax
time frame: 43 days
description: maximal concentration (Tmax)
measure: Pharmacokinetic parameters, AUC
time frame: 43 days
description: area under the plasma concentration curve (AUC)
measure: Pharmacokinetic parameters, CL/F
time frame: 43 days
description: clearance (CL/F).
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
time frame: 43 days
description: Evaluate the safety of single/multiple SQ doses of Pegilodecakin - Incidence of adverse events, injection site reactions, clinically relevant changes in laboratory values, EKGs, and vital signs
arm group label: 1
arm group type: Active Comparator
description: Pegilodecakin (5 μg/kg) dosed on Day 1, and Days 4-9 SQ
arm group label: 2
arm group type: Active Comparator
description: Pegilodecakin (10 μg/kg) dosed on Day 1, and Days 4-9 SQ
intervention type: Biological
intervention name: Pegilodecakin
description: Pegilodecakin Alone
arm group label: 1
arm group label: 2
other name: LY3500518
other name: AM0010
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 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 States
responsible party type: Sponsor
sharing ipd: No