<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/NCT02245828</url>
  </required_header>
  <id_info>
    <org_study_id>CQCC374X2101</org_study_id>
    <nct_id>NCT02245828</nct_id>
  </id_info>
  <brief_title>A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled First-in-human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374 in Healthy Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a double blind, randomized, placebo controlled, single and multiple ascending dose&#xD;
      study in healthy subjects. Safety evaluation will include (serious) adverse events, vital&#xD;
      signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be&#xD;
      drawn at specified timepoints.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety and tolerability</measure>
    <time_frame>39 days</time_frame>
    <description>Number of Participants with Adverse Events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>AUCinf</measure>
    <time_frame>39 days</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUClast</measure>
    <time_frame>39 days</time_frame>
    <description>The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCtau</measure>
    <time_frame>39 days</time_frame>
    <description>The area under the plasma concentration-time curve from time zero to the end of the dosing interval tau</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cav</measure>
    <time_frame>39 days</time_frame>
    <description>The average steady state plasma concentration during multiple dosing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>39 days</time_frame>
    <description>The observed maximum plasma concentration following drug administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T1/2</measure>
    <time_frame>39 days</time_frame>
    <description>The terminal elimination half life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>39 days</time_frame>
    <description>The time to reach the maximum concentration after drug administration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo comparator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>QCC374</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single and multiple ascending doses of QCC374</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>QCC374</intervention_name>
    <description>Single and multiple ascending doses of QCC374</description>
    <arm_group_label>QCC374</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo comparator</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent must be obtained before any assessment is performed.&#xD;
&#xD;
          2. Healthy male and female subjects age 18 to 55 years of age included, and in good&#xD;
             health as determined by past medical history, physical examination, vital signs,&#xD;
             electrocardiogram, and laboratory tests at screening.&#xD;
&#xD;
          3. Weight of at least 50 kg and body mass index (BMI) within the range of 18 - 32 kg/m2.&#xD;
             BMI = Body weight (kg) / [Height (m)]2.&#xD;
&#xD;
          4. Oxygen saturation (O2) at screening must be ≥ 95% on room air.&#xD;
&#xD;
          5. FEV1 ≥ 90% predicted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. 1. A history of clinically significant ECG abnormalities and/or orthostatic vital&#xD;
             signs at screening.&#xD;
&#xD;
          2. History of asthma or reactive airway diseases.&#xD;
&#xD;
          3. Smokers or anyone who smoked within 5 years of screening. Urine cotinine levels ≥ 500&#xD;
             ng/mL.&#xD;
&#xD;
          4. History of malignancy of any organ system other than localized basal cell carcinoma of&#xD;
             the skin, treated or untreated within the past 5 years, regardless of whether there is&#xD;
             evidence of local recurrence or metastases.&#xD;
&#xD;
          5. Women of child-bearing potential&#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>Novartis Investigative Site</name>
      <address>
        <city>Mid Glamorgan</city>
        <state>Wales</state>
        <zip>CF484DR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 22, 2014</study_first_posted>
  <last_update_submitted>March 20, 2016</last_update_submitted>
  <last_update_submitted_qc>March 20, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>healthy subjects, inhaled</keyword>
  <!-- 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/NCT02245828
org study id: CQCC374X2101
nct id: NCT02245828
lead sponsor: 
has dmc: No
This is a double blind, randomized, placebo controlled, single and multiple ascending dose
      study in healthy subjects. Safety evaluation will include (serious) adverse events, vital
      signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be
      drawn at specified timepoints.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Safety and tolerability
time frame: 39 days
description: Number of Participants with Adverse Events
measure: AUCinf
time frame: 39 days
description: Area under the plasma concentration-time curve from time zero to infinity
measure: AUClast
time frame: 39 days
description: The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
measure: AUCtau
time frame: 39 days
description: The area under the plasma concentration-time curve from time zero to the end of the dosing interval tau
measure: Cav
time frame: 39 days
description: The average steady state plasma concentration during multiple dosing
measure: Cmax
time frame: 39 days
description: The observed maximum plasma concentration following drug administration
measure: T1/2
time frame: 39 days
description: The terminal elimination half life
measure: Tmax
time frame: 39 days
description: The time to reach the maximum concentration after drug administration
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo comparator
arm group label: QCC374
arm group type: Experimental
description: Single and multiple ascending doses of QCC374
intervention type: Drug
intervention name: QCC374
description: Single and multiple ascending doses of QCC374
arm group label: QCC374
intervention type: Drug
intervention name: Placebo
description: Placebo comparator
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor