<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/NCT01719874</url>
  </required_header>
  <id_info>
    <org_study_id>TCN-032-002</org_study_id>
    <nct_id>NCT01719874</nct_id>
  </id_info>
  <brief_title>Influenza Virus Challenge Study to Test Monoclonal Antibody TCN-032 as a Treatment for Influenza</brief_title>
  <official_title>A Phase 2a, Double-Blind, Placebo-Controlled Study TCN 032 (Human Monoclonal Antibody Directed Against the M2 Protein of Influenza A Virus) in Subjects Challenged With H3N2 Influenza A Virus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Theraclone Sciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Theraclone Sciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety and efficacy of TCN-032 given to healthy&#xD;
      adult volunteers that have been inoculated with the influenza A virus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary objective is to evaluate the effect of TCN-032 compared to placebo in the development of clinical signs and symptoms of influenza (including upper respiratory, lower respiratory, systemic and fever).</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The main secondary objective is to evaluate the effect of TCN-032 compared to placebo in total virus shedding (measured by area under the curve [AUC]) from the nasal mucosa, measured by viral culture.</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) and immunogenicity of TCN-032</measure>
    <time_frame>up to 28 days after viral challenge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in haemagglutination-inhibiting antibody (HAI) titre pre-challenge to Day 28.</measure>
    <time_frame>28 days after viral challenge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of viral resistance to TCN-032</measure>
    <time_frame>up to 9 days after viral challenge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the safety of subjects who undergo influenza A viral challenge, with or without treatment with TCN-032.</measure>
    <time_frame>up to 28 days after viral challenge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of influenza symptoms or pyrexia</measure>
    <time_frame>up to 10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to peak of influenza symptoms or pyrexia</measure>
    <time_frame>up to 10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The daily incidence of influenza symptoms or pyrexia.</measure>
    <time_frame>up to 10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to peak of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The proportion of any grade influenza symptoms, or pyrexia</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of any grade influenza symptoms, or pyrexia</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to peak of any grade influenza symptoms, or pyrexia</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The daily incidence of any grade influenza symptoms, or pyrexia</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The peak value of virus shedding from the nasal mucosa measured by viral culture</measure>
    <time_frame>up to 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to peak of virus shedding from the nasal mucosa measured by viral culture</measure>
    <time_frame>up to 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of virus shedding from the nasal mucosa measured by viral culture</measure>
    <time_frame>up to 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The daily incidence of virus shedding from the nasal mucosa measured by viral culture</measure>
    <time_frame>up to 9 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The AUC of virus shedding from the nasal mucosa measured by qPCR</measure>
    <time_frame>6 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The peak value of virus shedding from the nasal mucosa measured by qPCR</measure>
    <time_frame>6 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The time to peak of virus shedding from the nasal mucosa measured by qPCR</measure>
    <time_frame>6 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The duration of virus shedding from the nasal mucosa measured by qPCR</measure>
    <time_frame>6 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The daily incidence of virus shedding from the nasal mucosa measured by qPCR</measure>
    <time_frame>6 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of seroconversion to viral challenge strain</measure>
    <time_frame>up to 28 days after viral challenge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of seroprotection to viral challenge strain</measure>
    <time_frame>up to 28 days after viral challenge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total tissue count and total mucus weight after viral inoculation</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">64</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>TCN-032</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>single-dose, administered intravenously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo (saline)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>single-dose, administered intravenously</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TCN-032</intervention_name>
    <arm_group_label>TCN-032</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo (saline)</intervention_name>
    <arm_group_label>Placebo (saline)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 to 45 years, inclusive.&#xD;
&#xD;
          -  In good health with no history of major medical conditions&#xD;
&#xD;
          -  Female subjects must not be pregnant or nursing&#xD;
&#xD;
          -  Have not been vaccinated for influenza virus since 2006&#xD;
&#xD;
          -  Serosusceptible to the challenge virus&#xD;
&#xD;
          -  Non-smoker or current smoker willing/able to desist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any significant acute or chronic, uncontrolled medical or psychiatric&#xD;
             illness&#xD;
&#xD;
          -  History or evidence of autoimmune disease&#xD;
&#xD;
          -  Any history during adulthood of asthma, history of COPD, pulmonary hypertension,&#xD;
             reactive airway disease, any chronic lung condition of any etiology), or any use of a&#xD;
             bronchodilator or other asthma medication within adulthood&#xD;
&#xD;
          -  History or clinical evidence of recurrent lower respiratory tract infection&#xD;
&#xD;
          -  Positive human immunodeficiency virus (HIV), hepatitis B (HBV), or hepatitis C (HCV)&#xD;
             antibody screen&#xD;
&#xD;
          -  Subject is diabetic&#xD;
&#xD;
          -  History of frequent epistaxis (nose bleeds)&#xD;
&#xD;
          -  Any nasal or sinus surgery within 6 months of the screening visit&#xD;
&#xD;
          -  Recent and/or recurrent history of autonomic dysfunction (fainting, palpitations,&#xD;
             etc.)&#xD;
&#xD;
          -  Any laboratory test, ECG or spirometry which is abnormal and which is deemed by the&#xD;
             Investigator(s) to be clinically significant.&#xD;
&#xD;
          -  Any acute medical condition or significant past medical history of hepatic, renal,&#xD;
             cardiovascular, pulmonary, gastrointestinal, haematological, locomotor, immunologic,&#xD;
             ophthalmologic, metabolic, endocrine, or other diseases&#xD;
&#xD;
          -  Major surgery within 3 months prior to screening visit&#xD;
&#xD;
          -  Evidence of drug of abuse or positive urine Class A drug or alcohol screen prior to&#xD;
             admission&#xD;
&#xD;
          -  Subjects symptomatic with hay fever&#xD;
&#xD;
          -  Subjects with a history of significant adverse reactions/allergies&#xD;
&#xD;
          -  History of allergy or intolerance to oseltamivir or zanamivir.&#xD;
&#xD;
          -  Health care workers (including doctors, nurses, medical students, and allied&#xD;
             healthcare professionals) anticipated to have patient contact within 2 weeks of viral&#xD;
             challenge.&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Eleanor L Ramos, MD</last_name>
    <role>Study Director</role>
    <affiliation>Theraclone Sciences, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jennifer L. Mitcham</last_name>
    <phone>206-805-1608</phone>
    <email>jmitcham@theraclone-sciences.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Teri D. Koller</last_name>
    <phone>206-805-1635</phone>
    <email>tkoller@theraclone-sciences.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>monoclonal antibody</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>March 19, 2014</submitted>
    <returned>April 25, 2014</returned>
    <submitted>April 25, 2014</submitted>
    <returned>May 23, 2014</returned>
  </pending_results>
  <!-- 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/NCT01719874
org study id: TCN-032-002
nct id: NCT01719874
lead sponsor: 
has dmc: No
The purpose of this study is to determine the safety and efficacy of TCN-032 given to healthy
      adult volunteers that have been inoculated with the influenza A virus
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The primary objective is to evaluate the effect of TCN-032 compared to placebo in the development of clinical signs and symptoms of influenza (including upper respiratory, lower respiratory, systemic and fever).
time frame: 7 days
measure: The main secondary objective is to evaluate the effect of TCN-032 compared to placebo in total virus shedding (measured by area under the curve [AUC]) from the nasal mucosa, measured by viral culture.
time frame: 7 days
measure: Pharmacokinetics (PK) and immunogenicity of TCN-032
time frame: up to 28 days after viral challenge
measure: Change in haemagglutination-inhibiting antibody (HAI) titre pre-challenge to Day 28.
time frame: 28 days after viral challenge
measure: Development of viral resistance to TCN-032
time frame: up to 9 days after viral challenge
measure: To evaluate the safety of subjects who undergo influenza A viral challenge, with or without treatment with TCN-032.
time frame: up to 28 days after viral challenge
measure: The duration of influenza symptoms or pyrexia
time frame: up to 10 days
measure: The time to peak of influenza symptoms or pyrexia
time frame: up to 10 days
measure: The daily incidence of influenza symptoms or pyrexia.
time frame: up to 10 days
measure: The proportion of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
time frame: 7 days
measure: The duration of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
time frame: 7 days
measure: The time to peak of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
time frame: 7 days
measure: The daily incidence of the components of the primary objective: upper respiratory symptoms, lower respiratory symptoms, systemic influenza symptoms, pyrexia.
time frame: 7 days
measure: The proportion of any grade influenza symptoms, or pyrexia
time frame: 7 days
measure: The duration of any grade influenza symptoms, or pyrexia
time frame: 7 days
measure: The time to peak of any grade influenza symptoms, or pyrexia
time frame: 7 days
measure: The daily incidence of any grade influenza symptoms, or pyrexia
time frame: 7 days
measure: The peak value of virus shedding from the nasal mucosa measured by viral culture
time frame: up to 9 days
measure: The time to peak of virus shedding from the nasal mucosa measured by viral culture
time frame: up to 9 days
measure: The duration of virus shedding from the nasal mucosa measured by viral culture
time frame: up to 9 days
measure: The daily incidence of virus shedding from the nasal mucosa measured by viral culture
time frame: up to 9 days
measure: The AUC of virus shedding from the nasal mucosa measured by qPCR
time frame: 6 days
measure: The peak value of virus shedding from the nasal mucosa measured by qPCR
time frame: 6 days
measure: The time to peak of virus shedding from the nasal mucosa measured by qPCR
time frame: 6 days
measure: The duration of virus shedding from the nasal mucosa measured by qPCR
time frame: 6 days
measure: The daily incidence of virus shedding from the nasal mucosa measured by qPCR
time frame: 6 days
measure: Incidence of seroconversion to viral challenge strain
time frame: up to 28 days after viral challenge
measure: Incidence of seroprotection to viral challenge strain
time frame: up to 28 days after viral challenge
measure: Total tissue count and total mucus weight after viral inoculation
time frame: 7 days
arm group label: TCN-032
arm group type: Experimental
description: single-dose, administered intravenously
arm group label: Placebo (saline)
arm group type: Placebo Comparator
description: single-dose, administered intravenously
intervention type: Biological
intervention name: TCN-032
arm group label: TCN-032
intervention type: Biological
intervention name: Placebo (saline)
arm group label: Placebo (saline)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Eleanor L Ramos, MD
role: Study Director
affiliation: Theraclone Sciences, Inc.
last name: Jennifer L. Mitcham
phone: 206-805-1608
email: jmitcham@theraclone-sciences.com
last name: Teri D. Koller
phone: 206-805-1635
email: tkoller@theraclone-sciences.com
facility: 
status: Recruiting
country: United Kingdom
responsible party type: Sponsor
mesh term: Influenza, Human
submitted: March 19, 2014
returned: April 25, 2014
submitted: April 25, 2014
returned: May 23, 2014