<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/NCT04497662</url>
  </required_header>
  <id_info>
    <org_study_id>KPL-404-C101</org_study_id>
    <nct_id>NCT04497662</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects</brief_title>
  <official_title>A Phase 1 First-in-human Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of KPL-404 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kiniksa Pharmaceuticals, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kiniksa Pharmaceuticals, Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the&#xD;
      safety, tolerability, PK and PD properties of single ascending intravenous (IV) and&#xD;
      subcutaneous (SC) doses of KPL-404 in healthy subjects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study includes 2 single ascending dose (SAD) parts; (Part A) IV SAD (up to 5 planned&#xD;
      dose level cohorts) and Part B SC SAD (up to 3 planned dose level cohorts).&#xD;
&#xD;
      Safety assessments will include adverse events (AEs), concomitant medications, clinical&#xD;
      laboratory, vital signs, 12-lead electrocardiogram, and physical examination. Serial blood&#xD;
      samples for PK, PD, and anti-drug antibodies will be performed during each part of the study&#xD;
      during the Treatment and Safety Evaluation Period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 22, 2019</start_date>
  <completion_date type="Actual">March 2, 2021</completion_date>
  <primary_completion_date type="Actual">January 21, 2021</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>Sequential Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>TEAEs following IV dosing</measure>
    <time_frame>Up to 65 days post dose</time_frame>
    <description>After single ascending IV doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) IV placebo group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TEAEs following SC dosing</measure>
    <time_frame>Up to 65 days post dose</time_frame>
    <description>After single ascending SC doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) SC placebo group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>KPL-404 (IV Administration)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>KPL-404 (SC Administration)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KPL-404</intervention_name>
    <description>humanized IgG4 monoclonal antibody</description>
    <arm_group_label>KPL-404 (IV Administration)</arm_group_label>
    <arm_group_label>KPL-404 (SC Administration)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Matching Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>KPL-404 (IV Administration)</arm_group_label>
    <arm_group_label>KPL-404 (SC Administration)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects&#xD;
&#xD;
          -  Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Poor peripheral venous access&#xD;
&#xD;
          -  Clinically-significant illness within 4 weeks of dose administration&#xD;
&#xD;
          -  Active or acute infection requiring systemic antibiotic treatment within 2 weeks prior&#xD;
             to Screening&#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>PPD Clinic</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78744</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Q-Pharm Pty Ltd</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4006</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>May 3, 2021</last_update_submitted>
  <last_update_submitted_qc>May 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2021</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/NCT04497662
org study id: KPL-404-C101
nct id: NCT04497662
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the
      safety, tolerability, PK and PD properties of single ascending intravenous (IV) and
      subcutaneous (SC) doses of KPL-404 in healthy subjects
This study includes 2 single ascending dose (SAD) parts; (Part A) IV SAD (up to 5 planned
      dose level cohorts) and Part B SC SAD (up to 3 planned dose level cohorts).

      Safety assessments will include adverse events (AEs), concomitant medications, clinical
      laboratory, vital signs, 12-lead electrocardiogram, and physical examination. Serial blood
      samples for PK, PD, and anti-drug antibodies will be performed during each part of the study
      during the Treatment and Safety Evaluation Period.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: TEAEs following IV dosing
time frame: Up to 65 days post dose
description: After single ascending IV doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) IV placebo group
measure: TEAEs following SC dosing
time frame: Up to 65 days post dose
description: After single ascending SC doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) SC placebo group
arm group label: KPL-404 (IV Administration)
arm group type: Experimental
arm group label: KPL-404 (SC Administration)
arm group type: Experimental
intervention type: Drug
intervention name: KPL-404
description: humanized IgG4 monoclonal antibody
arm group label: KPL-404 (IV Administration)
arm group label: KPL-404 (SC Administration)
intervention type: Other
intervention name: Matching Placebo
description: Placebo
arm group label: KPL-404 (IV Administration)
arm group label: KPL-404 (SC Administration)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Australia
country: United States
responsible party type: Sponsor
sharing ipd: No