xml: <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/NCT06007638</url>
    </required_header>
    <id_info>
      <org_study_id>18734</org_study_id>
      <secondary_id>J4K-MC-LALA</secondary_id>
      <secondary_id>2023-504838-21</secondary_id>
      <nct_id>NCT06007638</nct_id>
    </id_info>
    <brief_title>A Study of LY3876602 in Healthy Participants</brief_title>
    <official_title>A Randomised Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3876602 in Healthy Participants</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>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The main purpose of this study is to evaluate the safety and tolerability of LY3876602 after&#xD;
        administering as single ascending doses and following a data review proceeding to multiple&#xD;
        ascending doses in healthy participants. The blood tests will also be performed to check how&#xD;
        much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes&#xD;
        the body to eliminate it.&#xD;
  &#xD;
        The study will last up to approximately 17 weeks. A subgroup of participants will be&#xD;
        consented for CSF collections.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 22, 2023</start_date>
    <completion_date type="Anticipated">February 18, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 18, 2025</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration</measure>
      <time_frame>Baseline up to 17 weeks</time_frame>
      <description>Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602</measure>
      <time_frame>Predose up to 17 weeks</time_frame>
      <description>PK: AUC of LY3876602</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK: Maximum Observed Drug Concentration (Cmax) of LY3876602</measure>
      <time_frame>Predose up to 17 weeks</time_frame>
      <description>PK: Cmax of LY3876602</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PK: Half-life (t1/2) of LY3876602</measure>
      <time_frame>Predose up to 17 weeks</time_frame>
      <description>PK: t1/2 of LY3876602</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>LY3876602</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single ascending doses of LY3876602 administered intravenously (IV).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo administered IV.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>LY3876602</intervention_name>
      <description>Administered IV.</description>
      <arm_group_label>LY3876602</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Administered IV.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and female participants who are overtly healthy as determined by medical&#xD;
               evaluation&#xD;
  &#xD;
            -  Have a body mass index with the range of 18 and less than or equal to (≤) 32 kilograms&#xD;
               per square meter (kg/m²)&#xD;
  &#xD;
            -  Male or female participants of nonchildbearing potential&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Have a family history, defined as a parent or first-degree relative, of genetic&#xD;
               neurodegenerative disorders&#xD;
  &#xD;
            -  Have allergies to diphenhydramine, epinephrine, or methylprednisolone&#xD;
  &#xD;
            -  Have serious or unstable medical conditions,&#xD;
  &#xD;
            -  History of skin wounding within 14 days of screening or current skin infection&#xD;
  &#xD;
            -  Are unwilling to stop alcohol consumption 48 hours prior to each dosing&#xD;
  &#xD;
            -  Have active or latent tuberculosis&#xD;
  &#xD;
            -  Participants in the cohorts undergoing lumbar puncture have an allergy to local&#xD;
               anesthetics&#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>
    <overall_contact>
      <last_name>There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or</last_name>
      <phone>1-317-615-4559</phone>
      <email>ClinicalTrials.gov@Lilly.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Pharmaceutical Research Associates Group B.V.</name>
        <address>
          <city>Groningen</city>
          <zip>9728</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <phone>+31 50 402 2386</phone>
      </contact>
      <investigator>
        <last_name>Renger Tiessen, Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</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>
  
  
text: 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/NCT06007638
  org study id: 18734
  secondary id: J4K-MC-LALA
  secondary id: 2023-504838-21
  nct id: NCT06007638
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main purpose of this study is to evaluate the safety and tolerability of LY3876602 after
        administering as single ascending doses and following a data review proceeding to multiple
        ascending doses in healthy participants. The blood tests will also be performed to check how
        much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes
        the body to eliminate it.
  
        The study will last up to approximately 17 weeks. A subgroup of participants will be
        consented for CSF collections.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  measure: Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
  time frame: Baseline up to 17 weeks
  description: Part A: A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
  measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602
  time frame: Predose up to 17 weeks
  description: PK: AUC of LY3876602
  measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3876602
  time frame: Predose up to 17 weeks
  description: PK: Cmax of LY3876602
  measure: PK: Half-life (t1/2) of LY3876602
  time frame: Predose up to 17 weeks
  description: PK: t1/2 of LY3876602
  arm group label: LY3876602
  arm group type: Experimental
  description: Single ascending doses of LY3876602 administered intravenously (IV).
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo administered IV.
  intervention type: Drug
  intervention name: LY3876602
  description: Administered IV.
  arm group label: LY3876602
  intervention type: Drug
  intervention name: Placebo
  description: Administered IV.
  arm group label: Placebo
  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
  last name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  phone: 1-317-615-4559
  email: ClinicalTrials.gov@Lilly.com
  facility: 
  contact: 
  investigator: 
  country: Netherlands
  responsible party type: Sponsor
  sharing ipd: No