<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/NCT03236844</url>
  </required_header>
  <id_info>
    <org_study_id>WP40052</org_study_id>
    <nct_id>NCT03236844</nct_id>
  </id_info>
  <brief_title>Relative Bioavailability of Gantenerumab Produced by G4 Process Versus G3 Process Following Subcutaneous (SC) Injection in Healthy Participants</brief_title>
  <official_title>A Multi-Center, Randomized, Open-Label, Single-Dose, Parallel Group Study to Investigate the Relative Bioavailability of Gantenerumab Produced With the G4 Process in Comparison to Gantenerumab Produced With the G3 Process Following Administration by Subcutaneous Injection in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the relative bioavailability of the high concentration&#xD;
      liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the&#xD;
      same HCLF of gantenerumab produced with the G3 process in healthy participants following&#xD;
      single SC dose administration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multi-center, randomized, open-label, single dose, parallel-group study will assess the&#xD;
      relative bioavailability and the safety and tolerability of gantenerumab produced with the G4&#xD;
      process in comparison to gantenerumab produced with the G3 process. All participants will&#xD;
      receive single SC dose of gantenerumab (manufactured by either the G3 or G4 process) on Day&#xD;
      1. The total duration of the study for each participant will be up to 21 weeks: Screening (up&#xD;
      to 8 weeks); In-clinic period (Days -1 to 3); Out-patient period (Days 4 up to 68); and&#xD;
      Safety Follow-up (up to 90 days after dosing).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Observed Plasma Concentration (Cmax) of Gantenerumab</measure>
    <time_frame>Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Plasma Concentration-Time Curve From Time Zero (Predose) to Extrapolated Infinite Time (AUC 0-inf)</measure>
    <time_frame>Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Local Pain Assessments Using Visual Analog Scale (VAS)</measure>
    <time_frame>After needle insertion, immediately postdose, 5 minutes (min), 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local Pain Assessments Using Verbal Rating Scale (VRS)</measure>
    <time_frame>After needle insertion, immediately postdose, 5 min, 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Reactivity Assessment: Percentage of Participants by Severity of Injection Site Reactions</measure>
    <time_frame>Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin Reactivity Assessment: Percentage of Participants by Size of Injection Site Reactions</measure>
    <time_frame>Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)</measure>
    <time_frame>AEs: From Day 1 to Day 85; SAEs: From signing informed consent to end of study (maximum up to 5 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Anti-Gantenerumab Antibodies</measure>
    <time_frame>Predose (any time before injection) on Day 1 and on Day 85</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Healthy Participants</condition>
  <arm_group>
    <arm_group_label>Gantenerumab G4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gantenerumab G3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gantenerumab</intervention_name>
    <description>Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).</description>
    <arm_group_label>Gantenerumab G3</arm_group_label>
    <arm_group_label>Gantenerumab G4</arm_group_label>
    <other_name>RO4909832</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy participant&#xD;
&#xD;
          -  Body mass index (BMI) between 18.0 and 30.0 kilograms per meter-square (kg/m^2),&#xD;
             inclusive&#xD;
&#xD;
          -  Body weight between 55 to 110 kg inclusive&#xD;
&#xD;
          -  Female participants with either non-childbearing potential or with childbearing&#xD;
             potential who commit to remain abstinent or use acceptable contraceptive methods&#xD;
             during the treatment period and until at least 6 months after the follow-up visit&#xD;
&#xD;
          -  Women of childbearing potential must have a negative serum pregnancy test result at&#xD;
             screening and Day 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of any clinically significant gastrointestinal, renal, hepatic,&#xD;
             broncho-pulmonary, neurological, psychiatric, cardio-vascular, endocrinological,&#xD;
             hematological or allergic disease, metabolic disorder, cancer, or cirrhosis&#xD;
&#xD;
          -  History or suspicion of drugs of abuse addiction&#xD;
&#xD;
          -  History or suspicion of alcohol addiction&#xD;
&#xD;
          -  Pregnant or breastfeeding, or intending to become pregnant during the study or within&#xD;
             17 weeks after the last dose of study drug&#xD;
&#xD;
          -  Prior administration of gantenerumab&#xD;
&#xD;
          -  Clinically significant abnormalities (as judged by the investigator) in laboratory&#xD;
             test results (including complete blood count, chemistry panel, and urinalysis)&#xD;
&#xD;
          -  Concomitant disease or condition that could interfere with, or treatment of which&#xD;
             might interfere with, the conduct of the study, or that would, in the opinion of the&#xD;
             investigator, pose an unacceptable risk to the participant in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 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>
      <name>PRA International Clinical Pharmacology Center (EDS US Clinic)</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRA</name>
      <address>
        <city>Marlton</city>
        <state>New Jersey</state>
        <zip>08053</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PRA Health Sciences</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>December 11, 2018</last_update_submitted>
  <last_update_submitted_qc>December 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 12, 2018</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/NCT03236844
org study id: WP40052
nct id: NCT03236844
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to assess the relative bioavailability of the high concentration
      liquid formulation (HCLF) of gantenerumab produced with the G4 process in comparison to the
      same HCLF of gantenerumab produced with the G3 process in healthy participants following
      single SC dose administration.
This multi-center, randomized, open-label, single dose, parallel-group study will assess the
      relative bioavailability and the safety and tolerability of gantenerumab produced with the G4
      process in comparison to gantenerumab produced with the G3 process. All participants will
      receive single SC dose of gantenerumab (manufactured by either the G3 or G4 process) on Day
      1. The total duration of the study for each participant will be up to 21 weeks: Screening (up
      to 8 weeks); In-clinic period (Days -1 to 3); Out-patient period (Days 4 up to 68); and
      Safety Follow-up (up to 90 days after dosing).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax) of Gantenerumab
time frame: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
measure: Area Under the Plasma Concentration-Time Curve From Time Zero (Predose) to Extrapolated Infinite Time (AUC 0-inf)
time frame: Predose (any time before injection), 1, 6, and 12 hours postdose (after injection) on Day 1; on Days 2, 3, 4, 5, 6, 7, 8, 12, 21, 29, 43, 64, and 85
measure: Local Pain Assessments Using Visual Analog Scale (VAS)
time frame: After needle insertion, immediately postdose, 5 minutes (min), 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
measure: Local Pain Assessments Using Verbal Rating Scale (VRS)
time frame: After needle insertion, immediately postdose, 5 min, 10 min, 20 min, 1 hour, and 6 hours postdose on Day 1; on Days 2 and 3
measure: Skin Reactivity Assessment: Percentage of Participants by Severity of Injection Site Reactions
time frame: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
measure: Skin Reactivity Assessment: Percentage of Participants by Size of Injection Site Reactions
time frame: Immediately postdose, 10 min, 1 hour, and 6 hours postdose on Day 1; on Day 3
measure: Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
time frame: AEs: From Day 1 to Day 85; SAEs: From signing informed consent to end of study (maximum up to 5 months)
measure: Percentage of Participants With Anti-Gantenerumab Antibodies
time frame: Predose (any time before injection) on Day 1 and on Day 85
arm group label: Gantenerumab G4
arm group type: Experimental
description: Participants will receive single dose of gantenerumab HCLF manufactured by G4 process on Day 1.
arm group label: Gantenerumab G3
arm group type: Experimental
description: Participants will receive single dose of gantenerumab HCLF manufactured by G3 process on Day 1.
intervention type: Drug
intervention name: Gantenerumab
description: Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).
arm group label: Gantenerumab G3
arm group label: Gantenerumab G4
other name: RO4909832
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor