<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/NCT04479644</url>
  </required_header>
  <id_info>
    <org_study_id>BRII-198-001</org_study_id>
    <nct_id>NCT04479644</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198</brief_title>
  <official_title>A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibody, BRII-198 Administered Intravenously to Healthy Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brii Biosciences Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TSB Therapeutics (Beijing) CO.LTD</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Brii Biosciences Limited</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a phase 1 study in which healthy adult volunteers will receive BRII-198 or placebo&#xD;
      and will be assessed for safety, tolerability, and pharmacokinetics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 13, 2020</start_date>
  <completion_date type="Actual">February 3, 2021</completion_date>
  <primary_completion_date type="Actual">February 3, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of adverse events (AEs) by CTCAE v5.0</measure>
    <time_frame>up to 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects with SAEs</measure>
    <time_frame>up to 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects with infusion-related reactions</measure>
    <time_frame>up to 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of subjects with hypersensitivity reactions</measure>
    <time_frame>up to 24 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Concentration of BRII-198</measure>
    <time_frame>up to 24 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BRII-198 dose level 1 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BRII-198 dose level 2 or placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BRII-198 dose level 3 or placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BRII-198</intervention_name>
    <description>BRII-198 given intravenously</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo given intravenously</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be 18 to 49 years of age inclusive;&#xD;
&#xD;
          -  Body weight ≤100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2&#xD;
             (inclusive);&#xD;
&#xD;
          -  Male or female;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any clinically significant chronic or acute medical condition that makes the volunteer&#xD;
             unsuitable for participation;&#xD;
&#xD;
          -  A history of significant hypersensitivity, intolerance, or allergy to any drug&#xD;
             compound;&#xD;
&#xD;
          -  History of alcohol or other substance abuse;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yao Zhang</last_name>
    <role>Study Director</role>
    <affiliation>TSB Therapeutics (Beijing) CO.LTD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigative Site</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>March 2, 2023</last_update_submitted>
  <last_update_submitted_qc>March 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19 phase I</keyword>
  <keyword>monoclonal antibody</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04479644
org study id: BRII-198-001
nct id: NCT04479644
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a phase 1 study in which healthy adult volunteers will receive BRII-198 or placebo
      and will be assessed for safety, tolerability, and pharmacokinetics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Incidence of adverse events (AEs) by CTCAE v5.0
time frame: up to 24 weeks
measure: Proportion of subjects with SAEs
time frame: up to 24 weeks
measure: Proportion of subjects with infusion-related reactions
time frame: up to 24 weeks
measure: Proportion of subjects with hypersensitivity reactions
time frame: up to 24 weeks
measure: Serum Concentration of BRII-198
time frame: up to 24 weeks
arm group label: Cohort 1
arm group type: Experimental
description: BRII-198 dose level 1 or placebo
arm group label: Cohort 2
arm group type: Experimental
description: BRII-198 dose level 2 or placebo
arm group label: Cohort 3
arm group type: Experimental
description: BRII-198 dose level 3 or placebo
intervention type: Drug
intervention name: BRII-198
description: BRII-198 given intravenously
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
intervention type: Drug
intervention name: Placebo
description: Placebo given intravenously
arm group label: Cohort 1
arm group label: Cohort 2
arm group label: Cohort 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yao Zhang
role: Study Director
affiliation: TSB Therapeutics (Beijing) CO.LTD
facility: 
country: China
responsible party type: Sponsor
mesh term: COVID-19
sharing ipd: No