<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/NCT04449939</url>
  </required_header>
  <id_info>
    <org_study_id>KY1005-CT04</org_study_id>
    <nct_id>NCT04449939</nct_id>
  </id_info>
  <brief_title>A Study of Subcutaneous KY1005 in Healthy Volunteers</brief_title>
  <official_title>A Phase I, Open-label Study to Assess the Pharmacokinetics of KY1005 After Single Dose Administration by Subcutaneous and Intravenous Route in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kymab Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kymab Limited</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Single centre, open-label, single dose, parallel group study to investigate the PK, safety&#xD;
      and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration,&#xD;
      with i.v. KY1005 as a reference treatment.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 7, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after s.c. and i.v. administration, with i.v. KY1005 as a reference treatment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum observed concentration (Cmax) after infusion</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time at which Cmax is observed after infusion (tmax)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration time curve from time 0 to last observation (AUC 0-t)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the concentration time curve from time 0 to infinity (AUC0-inf)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic clearance after i.v. infusion (CL)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent systemic clearance after s.c. injection (CL/F)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of distribution during the terminal phase after i.v. infusion (Vz)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Apparent volume of distribution after s.c. injection (Vz/F)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Steady-state volume of distribution after i.v. infusion (Vss)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight-normalised Vss and Vz</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Half-life t½</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration</measure>
    <time_frame>Baseline to day 92</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of TEAE</measure>
    <time_frame>Baseline to day 92</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of TESAE</measure>
    <time_frame>Baseline to day 92</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of local injection site reactions</measure>
    <time_frame>Baseline to day 92</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in blood pressure mmHg (as a measure of safety and tolerability)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in heart rate bpm (as a measure of safety and tolerability)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in tympanic temperature °C (as a measure of safety and tolerability)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability)</measure>
    <time_frame>Baseline to day 92</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Serum anti-KY1005 antibody titres</measure>
    <time_frame>Baseline to day 92</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Incidence of anti-KY1005 antibodies</measure>
    <time_frame>Baseline to day 92</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Immune System Diseases</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of KY1005 by i.v. infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single lower dose KY1005 by s.c. injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single higher dose KY1005 by s.c. injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KY1005</intervention_name>
    <description>A human anti-OX40 ligand monoclonal antibody</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male, aged 18-45 years at screening&#xD;
&#xD;
          -  Body weight 60-120 kg&#xD;
&#xD;
          -  Body mass index (BMI) in the range 18.0-30.0 kg/m^2 (inclusive)&#xD;
&#xD;
          -  Deemed healthy on the basis of a clinical history, physical examination, ECG, vital&#xD;
             signs and laboratory tests of blood and urine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant abnormal findings at the screening assessment; acute or chronic&#xD;
             illness; clinically relevant abnormal medical history or concurrent medical condition;&#xD;
             positive tests for hepatitis B, hepatitis C, Human Immunodeficiency Virus (HIV)&#xD;
&#xD;
          -  Drug or alcohol abuse&#xD;
&#xD;
          -  Use of over-the-counter medication (with the exception of paracetamol [acetaminophen])&#xD;
             during the 7 days before the first dose of trial medication, or prescribed medication&#xD;
             during the 28 days before first dose of trial medication&#xD;
&#xD;
          -  Participation in other clinical trials of unlicensed medicines within the 3 months or&#xD;
             5 half-lives, whichever is longer, before admission to this study&#xD;
&#xD;
          -  Loss of more than 400 mL blood, within the previous 3 months&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adeep Puri, MBBS JCPTGP MPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hammersmith Medicines Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hammersmith Medicines Research</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Immune System Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT04449939
org study id: KY1005-CT04
nct id: NCT04449939
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Single centre, open-label, single dose, parallel group study to investigate the PK, safety
      and tolerability of KY1005 after subcutaneous (s.c.) and intravenous (i.v.) administration,
      with i.v. KY1005 as a reference treatment.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Single centre, open-label, single dose, parallel group study to investigate the PK, safety and tolerability of KY1005 after s.c. and i.v. administration, with i.v. KY1005 as a reference treatment.
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum observed concentration (Cmax) after infusion
time frame: Baseline to day 92
measure: Time at which Cmax is observed after infusion (tmax)
time frame: Baseline to day 92
measure: Area under the concentration time curve from time 0 to last observation (AUC 0-t)
time frame: Baseline to day 92
measure: Area under the concentration time curve from time 0 to infinity (AUC0-inf)
time frame: Baseline to day 92
measure: Systemic clearance after i.v. infusion (CL)
time frame: Baseline to day 92
measure: Apparent systemic clearance after s.c. injection (CL/F)
time frame: Baseline to day 92
measure: Volume of distribution during the terminal phase after i.v. infusion (Vz)
time frame: Baseline to day 92
measure: Apparent volume of distribution after s.c. injection (Vz/F)
time frame: Baseline to day 92
measure: Steady-state volume of distribution after i.v. infusion (Vss)
time frame: Baseline to day 92
measure: Weight-normalised Vss and Vz
time frame: Baseline to day 92
measure: Half-life t½
time frame: Baseline to day 92
measure: Dose-normalised Cmax (Cmax/D) following s.c. and i.v. administration
time frame: Baseline to day 92
measure: Absolute bioavailability (F) calculated as the ratio of AUC0-inf/D after i.v. and s.c. infusion
time frame: Baseline to day 92
measure: Dose-normalised AUC0-inf (AUC0-inf/D) following s.c. and i.v. administration
time frame: Baseline to day 92
measure: Occurrence of TEAE
time frame: Baseline to day 92
measure: Occurrence of TESAE
time frame: Baseline to day 92
measure: Occurrence of local injection site reactions
time frame: Baseline to day 92
measure: Changes in blood pressure mmHg (as a measure of safety and tolerability)
time frame: Baseline to day 92
measure: Changes in respiratory rate measured as breaths per minute (as a measure of safety and tolerability)
time frame: Baseline to day 92
measure: Changes in heart rate bpm (as a measure of safety and tolerability)
time frame: Baseline to day 92
measure: Changes in tympanic temperature °C (as a measure of safety and tolerability)
time frame: Baseline to day 92
measure: Changes in electrocardiograms PR, QR, QRS and QT intervals (as a measure of safety and tolerability)
time frame: Baseline to day 92
measure: Serum anti-KY1005 antibody titres
time frame: Baseline to day 92
measure: Incidence of anti-KY1005 antibodies
time frame: Baseline to day 92
arm group label: Group 1
arm group type: Experimental
description: Single dose of KY1005 by i.v. infusion
arm group label: Group 2
arm group type: Experimental
description: Single lower dose KY1005 by s.c. injection
arm group label: Group 3
arm group type: Experimental
description: Single higher dose KY1005 by s.c. injections
intervention type: Drug
intervention name: KY1005
description: A human anti-OX40 ligand monoclonal antibody
arm group label: Group 1
arm group label: Group 2
arm group label: Group 3
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Adeep Puri, MBBS JCPTGP MPhil
role: Principal Investigator
affiliation: Hammersmith Medicines Research
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Immune System Diseases