<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/NCT01676584</url>
  </required_header>
  <id_info>
    <org_study_id>BP28410</org_study_id>
    <nct_id>NCT01676584</nct_id>
  </id_info>
  <brief_title>A Study of Single Dose RO6811135 in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Healthy Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This randomized, double-blind, placebo-controlled study will evaluate the safety,&#xD;
      tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers.&#xD;
      Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135&#xD;
      or placebo subcutaneously.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety: Incidence of adverse events</measure>
    <time_frame>approximately 3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics: Area under the concentration-time curve</measure>
    <time_frame>Pre-dose and up to 96 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (blood analysis) of RO6811135</measure>
    <time_frame>96 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Healthy Volunteer</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>RO6811135</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>RO6811135</intervention_name>
    <description>single ascending doses sc</description>
    <arm_group_label>RO6811135</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>single doses sc</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female volunteers, 18 to 45 years of age inclusive&#xD;
&#xD;
          -  Body mass index (BMI) 22-32 kg/m2 inclusive&#xD;
&#xD;
          -  Females of child-bearing potential and males with female partners of child-bearing&#xD;
             potential must agree to use adequate contraception as defined by protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or presence of any clinically relevant disease or disorder&#xD;
&#xD;
          -  History of drug hypersensitivity or food allergies&#xD;
&#xD;
          -  Significant infection or known inflammatory process at screening or Day -1&#xD;
&#xD;
          -  Any history of alcohol and/or drug of abuse addiction&#xD;
&#xD;
          -  Alcohol consumption of more than 14 units (1 unit = 10 mL of pure alcohol) per week&#xD;
&#xD;
          -  Smoking more than 5 cigarettes a day or equivalent amount of tobacco&#xD;
&#xD;
          -  Positive for hepatitis B, hepatitis C or HIV infection&#xD;
&#xD;
          -  Participation in an investigational drug or device study within 3 months prior to&#xD;
             screening&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>August 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 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/NCT01676584
org study id: BP28410
nct id: NCT01676584
lead sponsor: 
This randomized, double-blind, placebo-controlled study will evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in healthy volunteers.
      Subjects will be randomized in cohorts to receive either single ascending doses of RO6811135
      or placebo subcutaneously.
allocation: Randomized
intervention model: Parallel Assignment
masking: Double (Participant, Investigator)
measure: Safety: Incidence of adverse events
time frame: approximately 3 months
measure: Pharmacokinetics: Area under the concentration-time curve
time frame: Pre-dose and up to 96 hours post-dose
measure: Pharmacodynamics (blood analysis) of RO6811135
time frame: 96 hours
arm group label: Placebo
arm group type: Placebo Comparator
arm group label: RO6811135
arm group type: Experimental
intervention type: Drug
intervention name: RO6811135
description: single ascending doses sc
arm group label: RO6811135
intervention type: Drug
intervention name: placebo
description: single doses sc
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
country: United States
responsible party type: Sponsor