<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/NCT02228707</url>
  </required_header>
  <id_info>
    <org_study_id>231HV102</org_study_id>
    <nct_id>NCT02228707</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biogen</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biogen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objectives of the study are to evaluate the safety and tolerability of multiple&#xD;
      doses of BIIB061 administered to healthy adults. The secondary objective is to determine the&#xD;
      multiple-dose PK profile of BIIB061 in this study population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Number of participants experiencing AEs</measure>
    <time_frame>Up to 28 days post treatment period (Day 1 to Day 56)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma BIIB061 Concentration</measure>
    <time_frame>Up to 28 days post treatment period (Day 1 to Day 56)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>BIIB061</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive BIIB061</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants receive matched placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIIB061</intervention_name>
    <description>Participants receive BIIB061</description>
    <arm_group_label>BIIB061</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matched placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Males and postmenopausal (defined as no menses for 12 months and confirmed by&#xD;
             follicle-stimulating hormone [FSH] levels determined at screening to be in the&#xD;
             postmenopausal range) or surgically sterile females&#xD;
&#xD;
          -  Must be in good health and have normal vital signs as determined by the Investigator,&#xD;
             based on medical history and screening evaluations.&#xD;
&#xD;
          -  Must agree to abstain from alcohol ingestion for the duration of the study.&#xD;
&#xD;
          -  Must agree to abstain from consumption of grapefruit or grapefruit-containing products&#xD;
             for the duration of the study, starting at least 24 hours prior to admission to the&#xD;
             inpatient facility.&#xD;
&#xD;
          -  Must agree to abstain from taking St. John's Wort (herbal preparation) for the&#xD;
             duration of the study&#xD;
&#xD;
          -  Must agree to abstain from any vigorous exercise (as determined by the Investigator)&#xD;
             for the duration of the study.&#xD;
&#xD;
          -  Must have a body mass index of 18 to 30 kg/m2, inclusive.&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  History of or positive test result at screening for human immunodeficiency virus,&#xD;
             hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B&#xD;
             surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).&#xD;
&#xD;
          -  Presence of a metal device (e.g., any type of electronic, mechanical, or magnetic&#xD;
             implant; cardiac pacemaker; aneurysm clips; implanted cardiac defibrillator) or&#xD;
             potential ferromagnetic foreign body (metal slivers, metal shavings, other metal&#xD;
             objects) that are contraindications for MRI.&#xD;
&#xD;
          -  History of asthma, wheezing, allergies involving the lungs, or airway obstruction.&#xD;
&#xD;
          -  History of bronchodilator or inhaler use.&#xD;
&#xD;
          -  Clinically significant abnormal hematology or blood chemistry values, as determined by&#xD;
             the Investigator.&#xD;
&#xD;
          -  Inability or unwillingness to comply with study requirements.&#xD;
&#xD;
          -  Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec,&#xD;
             make the subject unsuitable for enrollment.&#xD;
&#xD;
        Note: Other protocol defined inclusion/ exclusion criteria may apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Biogen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>June 14, 2016</last_update_submitted>
  <last_update_submitted_qc>June 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 15, 2016</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/NCT02228707
org study id: 231HV102
nct id: NCT02228707
lead sponsor: 
has dmc: No
The primary objectives of the study are to evaluate the safety and tolerability of multiple
      doses of BIIB061 administered to healthy adults. The secondary objective is to determine the
      multiple-dose PK profile of BIIB061 in this study population.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of participants experiencing AEs
time frame: Up to 28 days post treatment period (Day 1 to Day 56)
measure: Plasma BIIB061 Concentration
time frame: Up to 28 days post treatment period (Day 1 to Day 56)
arm group label: BIIB061
arm group type: Experimental
description: Participants receive BIIB061
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants receive matched placebo
intervention type: Drug
intervention name: BIIB061
description: Participants receive BIIB061
arm group label: BIIB061
intervention type: Other
intervention name: Placebo
description: Matched placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Biogen
facility: 
country: United States
responsible party type: Sponsor