<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/NCT02243189</url>
  </required_header>
  <id_info>
    <org_study_id>CR105491</org_study_id>
    <secondary_id>43260295HRV1003</secondary_id>
    <nct_id>NCT02243189</nct_id>
  </id_info>
  <brief_title>Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in Healthy Participants, and Atopic Participants With Mild to Mild-Persistent Asthma</brief_title>
  <official_title>A Phase 1 Study to Examine the Cytokine Levels, Gene Expression and Safety of a Single Nasal Dose of JNJ-43260295, in a Double-Blind, Randomized, Placebo-Controlled Setting in Healthy Subjects, and by an Open-Label Assessment in Atopic Subjects With Mild to Mild-Persistent Asthma With and Without Nasal Allergen Challenge Prior to Dosing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the cytokine levels in nasal lavage and gene&#xD;
      expression in nasal scraping following a single nasal dose of JNJ-43260295 in healthy&#xD;
      participants, and in atopic mild to mild-persistent asthmatic (breathing disorder in which&#xD;
      there is wheezing and difficulty in breathing) participants with and without nasal allergen&#xD;
      challenge prior to dosing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of 2 parts. In first part, healthy adult participants will receive a&#xD;
      single nasal dose of JNJ-43260295 or placebo in a double blind (both the participant and&#xD;
      investigator do not know whether participant is assigned to receive study medication or&#xD;
      placebo), randomized (study medication or placebo assigned to participants by chance), and&#xD;
      placebo-controlled (study in which the experimental treatment or procedure is compared to a&#xD;
      placebo) setting. In second part, which will be open label (participants and investigators&#xD;
      are aware about the treatment, participants are receiving), atopic participants with mild to&#xD;
      mild-persistent asthma will participate in 3 consecutive treatment periods (Period 1, 2, and&#xD;
      3). In Period 1, each participant will receive a single nasal dose of JNJ-43260295 without&#xD;
      prior nasal allergen challenge. In Period 2, each participant will receive a single nasal&#xD;
      dose of JNJ-43260295, preceded by a nasal allergen challenge approximately 15 hours prior to&#xD;
      the JNJ-43260295 dosing. In Period 3, each participant will receive single nasal allergen&#xD;
      challenge without JNJ-43260295. There will be a washout period of at least 21 days between 3&#xD;
      consecutive treatment periods. Cytokine levels in nasal lavage and gene expression in nasal&#xD;
      scraping will be primarily evaluated during all treatment periods. Participants' safety will&#xD;
      be monitored throughout the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Under enrollment and IP supply expiring.&#xD;
  </why_stopped>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Cytokine Levels in Nasal Lavage</measure>
    <time_frame>Up to 48 hours post dose</time_frame>
    <description>Sixteen cytokines will be assessed: interferon alpha (IFN-alpha), IFN-beta, IFN-gamma, IFN-lambda, interleukin-1 alpha (IL-1 alpha), IL-4, IL-5, IL-6, IL 8, IL-10, IL-12p70, IL-13, IL-15, IL-17, IL-23, and tumor necrosis factor-alpha (TNF-alpha), using the 16-plex kit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gene Expression in Nasal Scrapings</measure>
    <time_frame>Up to 48 hours post dose</time_frame>
    <description>Gene expression will be determined by analyzing total ribonucleic acid (RNA) by microarray chips.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)</measure>
    <time_frame>AEs: Baseline up to 8 days after the last dose of study drug; SAEs: Baseline up to 30 days after the last dose of study drug</time_frame>
    <description>An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Healthy</condition>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>JNJ-43260295 (Healthy Participants)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive a single nasal dose of JNJ-43260295, 6400 microgram, equally spread over the two nostrils.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (Healthy Participants)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants will receive a single nasal dose of placebo matching to JNJ-43260295.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JNJ-43260295 (Asthmatic Participants)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will participate in 3 consecutive treatment periods (Periods 1, 2, and 3). In Period 1, each participant will receive a single nasal dose of JNJ-43260295 without prior nasal allergen challenge. In Period 2, each participant will receive a single nasal dose of JNJ-43260295, preceded by a nasal allergen challenge approximately 15 hours prior to the dosing. In Period 3, each participant will receive single nasal allergen challenge without JNJ-43260295. There will be a washout period of at least 21 days between 3 consecutive treatment periods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-43260295</intervention_name>
    <description>A single nasal dose of JNJ-43260295, 6400 microgram, will be given.</description>
    <arm_group_label>JNJ-43260295 (Asthmatic Participants)</arm_group_label>
    <arm_group_label>JNJ-43260295 (Healthy Participants)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A single nasal dose of placebo matching to JNJ-43260295 will be given.</description>
    <arm_group_label>Placebo (Healthy Participants)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nasal Allergen Challenge</intervention_name>
    <description>Participants will be challenged by the nasal route with an appropriate allergen based on skin test reactivity.</description>
    <arm_group_label>JNJ-43260295 (Asthmatic Participants)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A. Healthy Participants and Atopic Mild to Mild-Persistent Asthmatic Participants:&#xD;
&#xD;
          -  Participants must be non-smokers or non-regular smokers (1 to 2 cigarettes on the&#xD;
             weekend as part of social gathering) for at least 3 months prior to Screening,&#xD;
             according to the participant's self-reported medical history. Participants should be&#xD;
             willing to (continue to) abstain from smoking from Screening until completion of the&#xD;
             last study related activity&#xD;
&#xD;
          -  Participants must have a body mass index (BMI: weight in kilogram [kg] divided by the&#xD;
             height in square meter [m^2]) of 18.0 to 30.0 kg/m^2, extremes included&#xD;
&#xD;
          -  Participants must have a normal 12-lead electrocardiogram (ECG) at Screening including&#xD;
             normal sinus rhythm (heart rate between 40 and 100 beats per minute [bpm]); QT&#xD;
             interval corrected for heart rate according to Fridericia (QTcF) interval less than&#xD;
             and equal to (&lt;=) 450 milliseconds (ms); QRS interval lower than 120 ms; and PR&#xD;
             interval &lt;=220 ms&#xD;
&#xD;
          -  Participants must be healthy, with the exception of findings related to asthma and&#xD;
             allergy in atopic mild to mild-Persistent asthmatic participants, on the basis of a&#xD;
             medical evaluation that reveals the absence of any clinically relevant abnormality and&#xD;
             includes a physical examination, medical history, vital signs (Systolic Blood Pressure&#xD;
             [BP], Diastolic BP, pulse rate, respiratory rate, and body temperature), and the&#xD;
             results of blood biochemistry and hematology tests performed at Screening&#xD;
&#xD;
          -  Participants must be willing/ able to adhere to the prohibitions and restrictions&#xD;
             specified in the protocol and study procedures&#xD;
&#xD;
        B. Atopic Mild to Mild-Persistent Asthmatic Participants:&#xD;
&#xD;
          -  Participants with Investigator-diagnosed mild to mild-persistent asthma based on the&#xD;
             Guidelines for the Diagnosis and Management of Asthma&#xD;
&#xD;
          -  Participants having a well-established allergen profile (participants have been&#xD;
             previously skin tested and, by history, have allergic responses to specific allergens)&#xD;
&#xD;
          -  Participants with forced expiratory volume in 1 second (FEV1) greater than (&gt;) 70&#xD;
             percent (%) of predicted at Baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A. Healthy Participants and Atopic Mild to Mild-Persistent Asthmatic Participants:&#xD;
&#xD;
          -  Participants having a significant (by the assessment of the Investigator) nasal&#xD;
             abnormality and/or has a history of nasal or sinus surgery within 12 months of&#xD;
             enrollment&#xD;
&#xD;
          -  Participants having an upper or lower respiratory tract infection within 4 weeks of&#xD;
             enrollment&#xD;
&#xD;
          -  Participants with a history or evidence of use of alcohol, barbiturates, amphetamines,&#xD;
             recreational or narcotic drug use within the past 1 year, which in the Investigator's&#xD;
             opinion would compromise participant's safety and/or compliance with the study&#xD;
             procedures&#xD;
&#xD;
          -  Participants with a known history of human immunodeficiency virus type 1 (HIV-1) or&#xD;
             HIV-2 infection, or with a known history of hepatitis A, B, or C virus infection at&#xD;
             study Screening&#xD;
&#xD;
          -  Female participants who are breastfeeding at Screening or having a positive urine&#xD;
             pregnancy test at Screening&#xD;
&#xD;
        B. Atopic Mild to Mild-Persistent Asthmatic Participants:&#xD;
&#xD;
          -  Hospitalization or treatment in an emergency care facility for asthma during the last&#xD;
             3 years&#xD;
&#xD;
          -  Participants using nasal corticosteroids on a daily basis in the 4 weeks prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Participants who have received allergen immunotherapy in the last 2 years&#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>Janssen Research &amp; Development, LLC Clinical Trial</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 16, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>March 22, 2016</last_update_submitted>
  <last_update_submitted_qc>March 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 23, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Healthy</keyword>
  <keyword>Asthma</keyword>
  <keyword>JNJ-43260295</keyword>
  <keyword>Nasal Allergen Challenge</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT02243189
org study id: CR105491
secondary id: 43260295HRV1003
nct id: NCT02243189
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the cytokine levels in nasal lavage and gene
      expression in nasal scraping following a single nasal dose of JNJ-43260295 in healthy
      participants, and in atopic mild to mild-persistent asthmatic (breathing disorder in which
      there is wheezing and difficulty in breathing) participants with and without nasal allergen
      challenge prior to dosing.
This study consists of 2 parts. In first part, healthy adult participants will receive a
      single nasal dose of JNJ-43260295 or placebo in a double blind (both the participant and
      investigator do not know whether participant is assigned to receive study medication or
      placebo), randomized (study medication or placebo assigned to participants by chance), and
      placebo-controlled (study in which the experimental treatment or procedure is compared to a
      placebo) setting. In second part, which will be open label (participants and investigators
      are aware about the treatment, participants are receiving), atopic participants with mild to
      mild-persistent asthma will participate in 3 consecutive treatment periods (Period 1, 2, and
      3). In Period 1, each participant will receive a single nasal dose of JNJ-43260295 without
      prior nasal allergen challenge. In Period 2, each participant will receive a single nasal
      dose of JNJ-43260295, preceded by a nasal allergen challenge approximately 15 hours prior to
      the JNJ-43260295 dosing. In Period 3, each participant will receive single nasal allergen
      challenge without JNJ-43260295. There will be a washout period of at least 21 days between 3
      consecutive treatment periods. Cytokine levels in nasal lavage and gene expression in nasal
      scraping will be primarily evaluated during all treatment periods. Participants' safety will
      be monitored throughout the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Cytokine Levels in Nasal Lavage
time frame: Up to 48 hours post dose
description: Sixteen cytokines will be assessed: interferon alpha (IFN-alpha), IFN-beta, IFN-gamma, IFN-lambda, interleukin-1 alpha (IL-1 alpha), IL-4, IL-5, IL-6, IL 8, IL-10, IL-12p70, IL-13, IL-15, IL-17, IL-23, and tumor necrosis factor-alpha (TNF-alpha), using the 16-plex kit.
measure: Gene Expression in Nasal Scrapings
time frame: Up to 48 hours post dose
description: Gene expression will be determined by analyzing total ribonucleic acid (RNA) by microarray chips.
measure: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
time frame: AEs: Baseline up to 8 days after the last dose of study drug; SAEs: Baseline up to 30 days after the last dose of study drug
description: An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly.
arm group label: JNJ-43260295 (Healthy Participants)
arm group type: Experimental
description: Participants will receive a single nasal dose of JNJ-43260295, 6400 microgram, equally spread over the two nostrils.
arm group label: Placebo (Healthy Participants)
arm group type: Placebo Comparator
description: Participants will receive a single nasal dose of placebo matching to JNJ-43260295.
arm group label: JNJ-43260295 (Asthmatic Participants)
arm group type: Experimental
description: Participants will participate in 3 consecutive treatment periods (Periods 1, 2, and 3). In Period 1, each participant will receive a single nasal dose of JNJ-43260295 without prior nasal allergen challenge. In Period 2, each participant will receive a single nasal dose of JNJ-43260295, preceded by a nasal allergen challenge approximately 15 hours prior to the dosing. In Period 3, each participant will receive single nasal allergen challenge without JNJ-43260295. There will be a washout period of at least 21 days between 3 consecutive treatment periods.
intervention type: Drug
intervention name: JNJ-43260295
description: A single nasal dose of JNJ-43260295, 6400 microgram, will be given.
arm group label: JNJ-43260295 (Asthmatic Participants)
arm group label: JNJ-43260295 (Healthy Participants)
intervention type: Drug
intervention name: Placebo
description: A single nasal dose of placebo matching to JNJ-43260295 will be given.
arm group label: Placebo (Healthy Participants)
intervention type: Drug
intervention name: Nasal Allergen Challenge
description: Participants will be challenged by the nasal route with an appropriate allergen based on skin test reactivity.
arm group label: JNJ-43260295 (Asthmatic Participants)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Janssen Research & Development, LLC Clinical Trial
role: Study Director
affiliation: Janssen Research & Development, LLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma