<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/NCT03002025</url>
  </required_header>
  <id_info>
    <org_study_id>CR108267</org_study_id>
    <secondary_id>64304500CRD1001</secondary_id>
    <nct_id>NCT03002025</nct_id>
  </id_info>
  <brief_title>A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Participants</brief_title>
  <official_title>A Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Subcutaneous Injection of JNJ-64304500 in Healthy Japanese and Caucasian Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Pharmaceutical K.K.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Pharmaceutical K.K.</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 primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics&#xD;
      (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese&#xD;
      male participants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2017</start_date>
  <completion_date type="Actual">September 9, 2017</completion_date>
  <primary_completion_date type="Actual">September 9, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum Observed Serum Concentration (Cmax)</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
    <description>The Cmax is the maximum observed serum analyte concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Reach Maximum Observed Serum Concentration (Tmax)</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
    <description>The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination Half-Life (t1/2)</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
    <description>Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Volume of Distribution (Vd/F)</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
    <description>The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent Total Clearance (CL/F)</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
    <description>The CL/F is defined as Dose/AUC (0-infinity).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
    <description>The AUC (0-last) is the area under the serum concentration-time curve from time zero to last quantifiable time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
    <description>The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibodies to JNJ-64304500</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
    <description>Serum samples will be collected and screened for antibodies binding to JNJ-64304500 and the titer of confirmed positive samples will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Natural Killer Group 2 Member D Receptor Occupancy (NKG2D RO) by JNJ-64304500</measure>
    <time_frame>Up to End of Study (Day 112)</time_frame>
    <description>Percentage of NKG2D receptors on natural killer (NK) cells and cluster of differentiation 8 (CD8)+ T cells that are occupied by JNJ-64304500 will be analyzed using a validated flow cytometry assay.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Cohort 1: JNJ-64304500 50 milligram (mg) or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (Japanese) will receive single subcutaneous (SC) dose of JNJ-64304500 50 mg or placebo on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: JNJ-64304500 150 mg or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (Japanese) will receive single SC dose of JNJ-64304500 150 mg or placebo on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3: JNJ-64304500 400 mg or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (Japanese) will receive single SC dose of JNJ-64304500 400 mg or placebo on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4: JNJ-64304500 150 mg or placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants (Caucasian) will receive single subcutaneous (SC) dose of JNJ-64304500 150 mg or placebo on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-64304500</intervention_name>
    <description>Participants will receive JNJ-64304500 as SC injection.</description>
    <arm_group_label>Cohort 1: JNJ-64304500 50 milligram (mg) or placebo</arm_group_label>
    <arm_group_label>Cohort 2: JNJ-64304500 150 mg or placebo</arm_group_label>
    <arm_group_label>Cohort 3: JNJ-64304500 400 mg or placebo</arm_group_label>
    <arm_group_label>Cohort 4: JNJ-64304500 150 mg or placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive matching placebo to JNJ-64304500 as SC injection.</description>
    <arm_group_label>Cohort 1: JNJ-64304500 50 milligram (mg) or placebo</arm_group_label>
    <arm_group_label>Cohort 2: JNJ-64304500 150 mg or placebo</arm_group_label>
    <arm_group_label>Cohort 3: JNJ-64304500 400 mg or placebo</arm_group_label>
    <arm_group_label>Cohort 4: JNJ-64304500 150 mg or placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant must have signed an informed consent document prior to any study related&#xD;
             procedures indicating that they understand the purpose of the study including the&#xD;
             procedures required and are willing to participate in the study&#xD;
&#xD;
          -  Participant must be willing and able to adhere to the study visit schedule,&#xD;
             prohibitions and restrictions specified in the protocol, and other protocol&#xD;
             requirements&#xD;
&#xD;
          -  Participant must have a body weight in the range of 60 to 90 kilogram (kg), inclusive,&#xD;
             and a body mass index (BMI) of 18 to 30 kilogram per square meter (kg/m^2)&#xD;
&#xD;
          -  Participant must be healthy on the basis of physical examination, medical history,&#xD;
             vital signs, and 12-lead electrocardiogram (ECG) performed at screening. This&#xD;
             determination must be recorded in the participant's source documents and initialed by&#xD;
             the investigator&#xD;
&#xD;
          -  Participant must be a non-smoker for at least 3 months prior to study enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has a history of or current clinically significant medical illness&#xD;
             including (but not limited to) cardiac arrhythmias or other cardiac disease,&#xD;
             hematologic disease, coagulation disorders (including any abnormal bleeding or blood&#xD;
             dyscrasias), lipid abnormalities, significant pulmonary disease, including&#xD;
             bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency,&#xD;
             thyroid disease, neurologic or psychiatric disease, infection, or any other illness&#xD;
             that the investigator considers should exclude the participant or that could interfere&#xD;
             with the interpretation of the study results&#xD;
&#xD;
          -  Participant has an active acute or chronic infection (including chronic recurrent or&#xD;
             invasive candidiasis) or diagnosed latent infection&#xD;
&#xD;
          -  Participant has or has had a serious infection (example, sepsis, pneumonia or&#xD;
             pyelonephritis), or have been hospitalized or received intravenous (IV) antibiotics&#xD;
             for a serious infection during the 2 months prior to screening&#xD;
&#xD;
          -  Participant has ever had a nontuberculous mycobacterial infection or opportunistic&#xD;
             infection (eg, cytomegalovirus, pneumocystosis, and aspergillosis) prior to screening&#xD;
&#xD;
          -  Participant has a history of active granulomatous infection, including histoplasmosis&#xD;
             or coccidioidomycosis prior to screening&#xD;
&#xD;
          -  If participant has had a chest radiograph within 3 months before study drug&#xD;
             administration radiograph that shows an abnormality suggestive of a malignancy or&#xD;
             current active infection, including tuberculosis (TB)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Pharmaceutical K.K., Japan Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Pharmaceutical K.K.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03002025
org study id: CR108267
secondary id: 64304500CRD1001
nct id: NCT03002025
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary purpose of this study is to assess the safety, tolerability, and pharmacokinetics
      (PK) following single-dose subcutaneous (SC) injection of JNJ-64304500 in healthy Japanese
      male participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability
time frame: Up to End of Study (Day 112)
measure: Maximum Observed Serum Concentration (Cmax)
time frame: Up to End of Study (Day 112)
description: The Cmax is the maximum observed serum analyte concentration.
measure: Time to Reach Maximum Observed Serum Concentration (Tmax)
time frame: Up to End of Study (Day 112)
description: The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
measure: Elimination Half-Life (t1/2)
time frame: Up to End of Study (Day 112)
description: Elimination half-life associated with the terminal slope Lambda (z) of the semi logarithmic drug concentration-time curve, calculated as 0.693/Lambda (z).
measure: Apparent Volume of Distribution (Vd/F)
time frame: Up to End of Study (Day 112)
description: The Vd/F is defined as Dose/[Lambda (z)*AUC (0-infinity)].
measure: Apparent Total Clearance (CL/F)
time frame: Up to End of Study (Day 112)
description: The CL/F is defined as Dose/AUC (0-infinity).
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
time frame: Up to End of Study (Day 112)
description: The AUC (0-last) is the area under the serum concentration-time curve from time zero to last quantifiable time.
measure: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
time frame: Up to End of Study (Day 112)
description: The AUC (0-infinity) is the area under the serum concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(last)/lambda(z); wherein AUC(0-last) is area under the serum concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
measure: Antibodies to JNJ-64304500
time frame: Up to End of Study (Day 112)
description: Serum samples will be collected and screened for antibodies binding to JNJ-64304500 and the titer of confirmed positive samples will be reported.
measure: Percentage of Natural Killer Group 2 Member D Receptor Occupancy (NKG2D RO) by JNJ-64304500
time frame: Up to End of Study (Day 112)
description: Percentage of NKG2D receptors on natural killer (NK) cells and cluster of differentiation 8 (CD8)+ T cells that are occupied by JNJ-64304500 will be analyzed using a validated flow cytometry assay.
arm group label: Cohort 1: JNJ-64304500 50 milligram (mg) or placebo
arm group type: Experimental
description: Participants (Japanese) will receive single subcutaneous (SC) dose of JNJ-64304500 50 mg or placebo on Day 1.
arm group label: Cohort 2: JNJ-64304500 150 mg or placebo
arm group type: Experimental
description: Participants (Japanese) will receive single SC dose of JNJ-64304500 150 mg or placebo on Day 1.
arm group label: Cohort 3: JNJ-64304500 400 mg or placebo
arm group type: Experimental
description: Participants (Japanese) will receive single SC dose of JNJ-64304500 400 mg or placebo on Day 1.
arm group label: Cohort 4: JNJ-64304500 150 mg or placebo
arm group type: Experimental
description: Participants (Caucasian) will receive single subcutaneous (SC) dose of JNJ-64304500 150 mg or placebo on Day 1.
intervention type: Drug
intervention name: JNJ-64304500
description: Participants will receive JNJ-64304500 as SC injection.
arm group label: Cohort 1: JNJ-64304500 50 milligram (mg) or placebo
arm group label: Cohort 2: JNJ-64304500 150 mg or placebo
arm group label: Cohort 3: JNJ-64304500 400 mg or placebo
arm group label: Cohort 4: JNJ-64304500 150 mg or placebo
intervention type: Drug
intervention name: Placebo
description: Participants will receive matching placebo to JNJ-64304500 as SC injection.
arm group label: Cohort 1: JNJ-64304500 50 milligram (mg) or placebo
arm group label: Cohort 2: JNJ-64304500 150 mg or placebo
arm group label: Cohort 3: JNJ-64304500 400 mg or placebo
arm group label: Cohort 4: JNJ-64304500 150 mg or placebo
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: Study Director
affiliation: Janssen Pharmaceutical K.K.
facility: 
country: Japan
responsible party type: Sponsor