<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/NCT03001297</url>
  </required_header>
  <id_info>
    <org_study_id>D7870C00001</org_study_id>
    <nct_id>NCT03001297</nct_id>
  </id_info>
  <brief_title>Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884</brief_title>
  <official_title>A Phase 1 Randomized, Blinded, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of MEDI5884 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedImmune LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese&#xD;
      cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in&#xD;
      healthy volunteers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a first time in human, phase 1, randomized, blinded, placebo-controlled study to&#xD;
      evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous&#xD;
      doses of MEDI5884 in healthy volunteers (age 18-55). The study consists of 4 cohorts of&#xD;
      increasing doses (8 subjects each) and an optional Japanese American cohort (24 subjects) for&#xD;
      a total of 56 healthy subjects. The decision whether or not to dose escalate will be based&#xD;
      upon data review by the Dose Escalation Committee. Subjects will be randomized 3:1 to&#xD;
      MEDI5884 or placebo. Following screening, the study consists of a 3 day inpatient stay and&#xD;
      follow up visits. The number of follow up visits depend on the cohort assigned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">August 10, 2018</completion_date>
  <primary_completion_date type="Actual">August 10, 2018</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>Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884</measure>
    <time_frame>Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.</time_frame>
    <description>Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884</measure>
    <time_frame>Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.</time_frame>
    <description>12 lead electrocardiogram (ECG) including RR (The time between corresponding points on 2 consecutive R waves on ECG), PR (ECG interval measured from the onset of the P wave to the onset of the QRS complex) , QRS (ECG interval measured from the onset of the QRS complex to the J point) , QT (ECG interval measured from the onset of the QRS complex to the end of the T wave), and QTc (QT interval corrected for heart rate) intervals</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884</measure>
    <time_frame>Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.</time_frame>
    <description>Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rates)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884</measure>
    <time_frame>Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.</time_frame>
    <description>Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HDL-Cholesterol over time</measure>
    <time_frame>Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.</time_frame>
    <description>HDL-Cholesterol over time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lipoprotein particle size</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Lipoprotein particle size</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipoprotein particle number</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Lipoprotein particle number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of total cholesterol</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Levels of total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-HDL-Cholesterol</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Non-HDL-Cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low-density lipoprotein cholesterol (direct and Friedewald equation)</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Low-density lipoprotein cholesterol (direct and Friedewald equation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Very low-density lipoprotein cholesterol</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Very low-density lipoprotein cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Triglycerides</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apolipoprotein B</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Apolipoprotein B</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apolipoprotein A1</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Apolipoprotein A1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MEDI5884 serum concentration: maximum observed concentration</measure>
    <time_frame>Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)</time_frame>
    <description>MEDI5884 serum concentration: maximum observed concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MEDI5884 serum concentration: time to maximum observed concentration</measure>
    <time_frame>Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)</time_frame>
    <description>MEDI5884 serum concentration:&#xD;
time to maximum observed concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MEDI5884 serum concentration: area under the concentration time curve</measure>
    <time_frame>Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)</time_frame>
    <description>MEDI5884 serum concentration: area under the concentration time curve</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MEDI5884 serum concentration: terminal half-life</measure>
    <time_frame>Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)</time_frame>
    <description>MEDI5884 serum concentration:&#xD;
terminal half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-drug antibody</measure>
    <time_frame>Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing</time_frame>
    <description>Anti-drug antibody</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>MEDI5884 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of MEDI5884 Dose 1 injection SC on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo will be administered subcutaneously (SC).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI5884 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of MEDI5884 Dose 2 injection SC on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI5884 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of MEDI5884 Dose 3 injection SC on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MEDI5884 Dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of MEDI5884 Dose 4 injection SC on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive single dose of placebo matched MEDI5884 injection SC on Day 1</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MEDI5884 Dose 1</intervention_name>
    <description>Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.</description>
    <arm_group_label>MEDI5884 Dose 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MEDI5884 Dose 2</intervention_name>
    <description>Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1</description>
    <arm_group_label>MEDI5884 Dose 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MEDI5884 Dose 3</intervention_name>
    <description>Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1</description>
    <arm_group_label>MEDI5884 Dose 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MEDI5884 Dose 4</intervention_name>
    <description>Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1</description>
    <arm_group_label>MEDI5884 Dose 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers aged 18-55 years&#xD;
&#xD;
          -  Must provide written informed consent&#xD;
&#xD;
          -  Ability and willingness to adhere to the protocol&#xD;
&#xD;
          -  BMI 18-30kg/m2&#xD;
&#xD;
          -  Females not of childbearing potential&#xD;
&#xD;
          -  Males must practice 2 effective contraceptive measures if sexually active&#xD;
&#xD;
          -  Japanese descent for the Japanese cohort&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any concurrent condition that in the opinion of the investigator would interfere with&#xD;
             the evaluation of the investigational product&#xD;
&#xD;
          -  History or presence of gastrointestinal, renal, or hepatic disease or any other&#xD;
             condition known to interfere with absorption, distribution, metabolism, or excretion&#xD;
             of drugs&#xD;
&#xD;
          -  Abnormal lab values, physical exam, vital signs&#xD;
&#xD;
          -  Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks&#xD;
             prior to dosing&#xD;
&#xD;
          -  Positive Hepatitis B, Hepatitis C or HIV test&#xD;
&#xD;
          -  Receipt of investigational therapy with 4 months from screening&#xD;
&#xD;
          -  Current or previous use of systemic corticosteroids 60 days prior to dosing or lipid&#xD;
             lowering medications 28 days prior to dosing&#xD;
&#xD;
          -  Abnormal ECG&#xD;
&#xD;
          -  Recent plasma or blood donation&#xD;
&#xD;
          -  Positive drug or alcohol screen.&#xD;
&#xD;
          -  Current smoker&#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>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Glendale</city>
        <state>California</state>
        <zip>91206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>August 21, 2018</last_update_submitted>
  <last_update_submitted_qc>August 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>atherosclerosis; acute coronary syndrome; MEDI5884</keyword>
  <!-- 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/NCT03001297
org study id: D7870C00001
nct id: NCT03001297
lead sponsor: 
has dmc: No
A Phase 1, single dose study with 4 cohorts of ascending doses and an optional Japanese
      cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of MEDI5884 in
      healthy volunteers
This is a first time in human, phase 1, randomized, blinded, placebo-controlled study to
      evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous
      doses of MEDI5884 in healthy volunteers (age 18-55). The study consists of 4 cohorts of
      increasing doses (8 subjects each) and an optional Japanese American cohort (24 subjects) for
      a total of 56 healthy subjects. The decision whether or not to dose escalate will be based
      upon data review by the Dose Escalation Committee. Subjects will be randomized 3:1 to
      MEDI5884 or placebo. Following screening, the study consists of a 3 day inpatient stay and
      follow up visits. The number of follow up visits depend on the cohort assigned.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
description: Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)
measure: Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
description: 12 lead electrocardiogram (ECG) including RR (The time between corresponding points on 2 consecutive R waves on ECG), PR (ECG interval measured from the onset of the P wave to the onset of the QRS complex) , QRS (ECG interval measured from the onset of the QRS complex to the J point) , QT (ECG interval measured from the onset of the QRS complex to the end of the T wave), and QTc (QT interval corrected for heart rate) intervals
measure: Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
description: Vital signs (systolic and diastolic blood pressure, pulse rate, temperature, and respiratory rates)
measure: Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
description: Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)
measure: HDL-Cholesterol over time
time frame: Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.
description: HDL-Cholesterol over time
measure: Lipoprotein particle size
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Lipoprotein particle size
measure: Lipoprotein particle number
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Lipoprotein particle number
measure: Levels of total cholesterol
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Levels of total cholesterol
measure: Non-HDL-Cholesterol
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Non-HDL-Cholesterol
measure: Low-density lipoprotein cholesterol (direct and Friedewald equation)
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Low-density lipoprotein cholesterol (direct and Friedewald equation)
measure: Very low-density lipoprotein cholesterol
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Very low-density lipoprotein cholesterol
measure: Triglycerides
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Triglycerides
measure: Apolipoprotein B
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Apolipoprotein B
measure: Apolipoprotein A1
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Apolipoprotein A1
measure: MEDI5884 serum concentration: maximum observed concentration
time frame: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
description: MEDI5884 serum concentration: maximum observed concentration
measure: MEDI5884 serum concentration: time to maximum observed concentration
time frame: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
description: MEDI5884 serum concentration:
time to maximum observed concentration
measure: MEDI5884 serum concentration: area under the concentration time curve
time frame: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
description: MEDI5884 serum concentration: area under the concentration time curve
measure: MEDI5884 serum concentration: terminal half-life
time frame: Post dose on Days 1, 2, 3, 7, 14, 21, 28, 45 (cohorts 2-4 and Japanese American), 60 (cohorts 3, 4 and Japanese American), 75 (cohort 4), and 90 (cohort 4)
description: MEDI5884 serum concentration:
terminal half-life
measure: Anti-drug antibody
time frame: Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
description: Anti-drug antibody
arm group label: MEDI5884 Dose 1
arm group type: Experimental
description: Participants will receive single dose of MEDI5884 Dose 1 injection SC on Day 1.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo will be administered subcutaneously (SC).
arm group label: MEDI5884 Dose 2
arm group type: Experimental
description: Participants will receive single dose of MEDI5884 Dose 2 injection SC on Day 1.
arm group label: MEDI5884 Dose 3
arm group type: Experimental
description: Participants will receive single dose of MEDI5884 Dose 3 injection SC on Day 1.
arm group label: MEDI5884 Dose 4
arm group type: Experimental
description: Participants will receive single dose of MEDI5884 Dose 4 injection SC on Day 1.
intervention type: Biological
intervention name: Placebo
description: Participants will receive single dose of placebo matched MEDI5884 injection SC on Day 1
arm group label: Placebo
intervention type: Biological
intervention name: MEDI5884 Dose 1
description: Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.
arm group label: MEDI5884 Dose 1
intervention type: Biological
intervention name: MEDI5884 Dose 2
description: Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1
arm group label: MEDI5884 Dose 2
intervention type: Biological
intervention name: MEDI5884 Dose 3
description: Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1
arm group label: MEDI5884 Dose 3
intervention type: Biological
intervention name: MEDI5884 Dose 4
description: Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1
arm group label: MEDI5884 Dose 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor