<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/NCT02202356</url>
  </required_header>
  <id_info>
    <org_study_id>ALS-8176-503</org_study_id>
    <secondary_id>2013-005104-33</secondary_id>
    <nct_id>NCT02202356</nct_id>
  </id_info>
  <brief_title>A Study of ALS-008176 in Infants Hospitalized With RSV</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alios Biopharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alios Biopharma Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect&#xD;
      of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial&#xD;
      virus (RSV)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 23, 2014</start_date>
  <completion_date type="Actual">February 15, 2018</completion_date>
  <primary_completion_date type="Actual">February 15, 2018</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Events</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Physical Examinations</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Vital Signs</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>12-Lead ECGs</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Laboratory Results</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>RSV viral RNA concentrations in nasal aspirates</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergence of resistance</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
    <description>Changes in RSV polymerase that result in reduced sensitivity to study drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters, including maximum and minimum drug concentrations</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters, including time to maximum concentration and half-life</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters, including area under concentration-time curves (AUCs)</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)</measure>
    <time_frame>Baseline through 6 days post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Respiratory Syncytial Virus Infections</condition>
  <arm_group>
    <arm_group_label>ALS-008176 Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of ALS-008176 administered orally as a suspension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Single Dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose of placebo administered orally as a suspension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALS-008176 Multiple Doses</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple doses of ALS-008176 administered orally as a suspension</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Multiple Doses</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Multiple doses of placebo administered orally as a suspension</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALS-008176</intervention_name>
    <arm_group_label>ALS-008176 Multiple Doses</arm_group_label>
    <arm_group_label>ALS-008176 Single Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo Multiple Doses</arm_group_label>
    <arm_group_label>Placebo Single Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the&#xD;
             time of hospital admission, or &lt;28 days of age (neonate cohort only). Note: all&#xD;
             subjects, including neonates, must have been discharged from the hospital after birth&#xD;
             and are now being admitted due to an RSV related illness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prematurity&#xD;
&#xD;
          -  Receiving invasive endotracheal mechanical ventilation&#xD;
&#xD;
          -  Poorly functioning gastrointestinal tract&#xD;
&#xD;
          -  Anticipated to be discharged from the hospital in &lt;24 hours from the time of&#xD;
             randomization&#xD;
&#xD;
          -  Prior exposure to palivizumab&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew McClure, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Alios BioPharma</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Children's Hospital Research Institute</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Long Beach Memorial Medical Center/Miller Children's and Women's Hospital of Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Orange County</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of California at San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSU Health Sciences Center</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Mercy</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27708</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Research Institute at Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital/University of Tennessee</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital/Baylor College of Medicine</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Canberra Hospital</name>
      <address>
        <city>Canberra</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Center</name>
      <address>
        <city>Melbourne</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's and Children's Hospital</name>
      <address>
        <city>North Adelaide</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Children's Hospital Melbourne</name>
      <address>
        <city>Parkville</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Perth</city>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital Research Institute of Manitoba</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Canadian Centre for Vaccinology IWK Health Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster Children's Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. Exequiel Gonzalez Cortes</name>
      <address>
        <city>San Miguel</city>
        <state>Santiago</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Complejo Asistencial Dr Sotero del Rio</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Padre Hurtado</name>
      <address>
        <city>Santiago</city>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacion Cardio Infantil Instituto de Cardiologia</name>
      <address>
        <city>Bogota</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Pablo Tobon Uribe</name>
      <address>
        <city>Medellin</city>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Pellegrin / Pneumologie pediatrique</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Necker</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hirosaki National Hospital</name>
      <address>
        <city>Hirosaki-shi</city>
        <state>Aomori</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chiba Children's Hospital</name>
      <address>
        <city>Chiba-shi</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ota Memorial Hospital</name>
      <address>
        <city>Ota</city>
        <state>Gunma</state>
        <zip>373-8585</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gunma Children's Medical Center</name>
      <address>
        <city>Shibukawa-shi</city>
        <state>Gunma</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Fukuyama Medical Center</name>
      <address>
        <city>Fukuyama</city>
        <state>Hiroshima</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido P.W.F.A.C. Asahikawa-Kosei General Hospital</name>
      <address>
        <city>Asahikawa-shi</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Kanazawa Medical Center</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Shikoku Medical Center for Children and Adults</name>
      <address>
        <city>Takamatsu</city>
        <state>Kagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okinawa Chubu Hospital</name>
      <address>
        <city>Urumi</city>
        <state>Okinawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nakano Children's Hospital</name>
      <address>
        <city>Osaka-city</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Saitama National Hospital</name>
      <address>
        <city>Wako</city>
        <state>Saitama</state>
        <zip>351-0102</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Children's Medical Center</name>
      <address>
        <city>Fuchu-shi</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Center for Child Health and Development</name>
      <address>
        <city>Setagaya-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fukuoka Children's Hospital</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHO Fukuoka Hospital</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kochi Health Sciences Center</name>
      <address>
        <city>Kochi</city>
        <zip>781-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Children's Medical Center</name>
      <address>
        <city>Saitama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Clinical Study Trust</name>
      <address>
        <city>Christchurch</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hawke's Bay Hospital</name>
      <address>
        <city>Hastings</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellington Hospital</name>
      <address>
        <city>Wellington</city>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Materno Infantil Jose Dominog de Obaldila</name>
      <address>
        <city>David</city>
        <state>Chiriqui</state>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Especialidades Pediatricas &quot;Omar Torrijos Herrera&quot;</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital del Nino</name>
      <address>
        <city>Panama City</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Mother and Child Care &quot;Alfred Rusescu&quot;</name>
      <address>
        <city>Bucharest</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>2 Military Hospital</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingsbury Hospital</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tygerberg Academic Hospital</name>
      <address>
        <city>Cape Town</city>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Linkou Chang Gung Medical Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MacKay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chulalongkorn University Department of Pediatrics</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phramongkutklao Hospital Department of Pediatrics</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siriraj Hospital, Mahidol University Department of Pediatrics</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khon Kaen University Department of Pediatrics</name>
      <address>
        <city>Khon Kaen</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Hospital for Children</name>
      <address>
        <city>Bristol</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alder Hey Children's Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. George's University of London</name>
      <address>
        <city>London</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Southampton NHS Foundation Trust</name>
      <address>
        <city>Southampton</city>
        <state>England</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Hospital for Sick Children</name>
      <address>
        <city>Edinburgh</city>
        <state>Scotland</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Wales</name>
      <address>
        <city>Cardiff</city>
        <state>Wales</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Children's Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Alexandra Children's Hospital</name>
      <address>
        <city>Brighton</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Manchester Children's Hospital</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens Medical Center</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oxford</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>Colombia</country>
    <country>France</country>
    <country>Japan</country>
    <country>New Zealand</country>
    <country>Panama</country>
    <country>Romania</country>
    <country>South Africa</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>RSV</keyword>
  <keyword>Respiratory Syncytial Virus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Respiratory Syncytial Virus Infections</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/NCT02202356
org study id: ALS-8176-503
secondary id: 2013-005104-33
nct id: NCT02202356
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect
      of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial
      virus (RSV)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse Events
time frame: Baseline through 6 days post-dose
measure: Physical Examinations
time frame: Baseline through 6 days post-dose
measure: Vital Signs
time frame: Baseline through 6 days post-dose
measure: 12-Lead ECGs
time frame: Baseline through 6 days post-dose
measure: Clinical Laboratory Results
time frame: Baseline through 6 days post-dose
measure: RSV viral RNA concentrations in nasal aspirates
time frame: Baseline through 6 days post-dose
measure: Emergence of resistance
time frame: Baseline through 6 days post-dose
description: Changes in RSV polymerase that result in reduced sensitivity to study drug
measure: Pharmacokinetic parameters, including maximum and minimum drug concentrations
time frame: Baseline through 6 days post-dose
measure: Pharmacokinetic parameters, including time to maximum concentration and half-life
time frame: Baseline through 6 days post-dose
measure: Pharmacokinetic parameters, including area under concentration-time curves (AUCs)
time frame: Baseline through 6 days post-dose
measure: Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F)
time frame: Baseline through 6 days post-dose
arm group label: ALS-008176 Single Dose
arm group type: Experimental
description: Single dose of ALS-008176 administered orally as a suspension
arm group label: Placebo Single Dose
arm group type: Placebo Comparator
description: Single dose of placebo administered orally as a suspension
arm group label: ALS-008176 Multiple Doses
arm group type: Experimental
description: Multiple doses of ALS-008176 administered orally as a suspension
arm group label: Placebo Multiple Doses
arm group type: Placebo Comparator
description: Multiple doses of placebo administered orally as a suspension
intervention type: Drug
intervention name: ALS-008176
arm group label: ALS-008176 Multiple Doses
arm group label: ALS-008176 Single Dose
intervention type: Drug
intervention name: Placebo
arm group label: Placebo Multiple Doses
arm group label: Placebo Single Dose
criteria: 
gender: All
minimum age: N/A
maximum age: 12 Months
healthy volunteers: No
last name: Matthew McClure, M.D.
role: Study Director
affiliation: Alios BioPharma
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country: Australia
country: Canada
country: Chile
country: Colombia
country: France
country: Japan
country: New Zealand
country: Panama
country: Romania
country: South Africa
country: Taiwan
country: Thailand
country: United Kingdom
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Respiratory Syncytial Virus Infections