<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/NCT04404023</url>
  </required_header>
  <id_info>
    <org_study_id>UBP-A124-IgE</org_study_id>
    <nct_id>NCT04404023</nct_id>
  </id_info>
  <brief_title>Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers</brief_title>
  <official_title>A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Single Dose of UB-221 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UBP Greater China (Shanghai) Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UBP Greater China (Shanghai) Co., Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics,&#xD;
      pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability,&#xD;
      pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy&#xD;
      volunteers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">December 1, 2023</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1.Adverse event incidence</measure>
    <time_frame>15 days</time_frame>
    <description>from the baseline to day 15 after IP infusion</description>
  </primary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Chronic Spontaneous Urticaria</condition>
  <arm_group>
    <arm_group_label>UB-221 (0.2 mg/kg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UB-221 (0.6 mg/kg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UB-221 (2 mg/kg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UB-221 (6 mg/kg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>UB-221 (10 mg/kg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intravenous infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>UB-221</intervention_name>
    <description>UB-221 (75 mg/ml)</description>
    <arm_group_label>UB-221 (0.2 mg/kg)</arm_group_label>
    <arm_group_label>UB-221 (0.6 mg/kg)</arm_group_label>
    <arm_group_label>UB-221 (10 mg/kg)</arm_group_label>
    <arm_group_label>UB-221 (2 mg/kg)</arm_group_label>
    <arm_group_label>UB-221 (6 mg/kg)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with age between 20 to 65 years old (inclusive).&#xD;
&#xD;
          -  Subjects who are able and willing to provide the informed consent.&#xD;
&#xD;
          -  Male subjects with body weight of 50 kilogram (kg) or above; female subjects body&#xD;
             weight of 45 kilogram (kg) or above.&#xD;
&#xD;
          -  Researchers based on medical history, physical examination, vital signs, clinical&#xD;
             laboratory results and 12-lead electrocardiogram identified healthy subjects without&#xD;
             clinically significant abnormalities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • The investigator considered that the subjects were not suitable to participate in this&#xD;
        study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>May 16, 2022</last_update_submitted>
  <last_update_submitted_qc>May 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urticaria</mesh_term>
    <mesh_term>Chronic Urticaria</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/NCT04404023
org study id: UBP-A124-IgE
nct id: NCT04404023
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics,
      pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.
This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability,
      pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy
      volunteers.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 1.Adverse event incidence
time frame: 15 days
description: from the baseline to day 15 after IP infusion
arm group label: UB-221 (0.2 mg/kg)
arm group type: Experimental
description: Intravenous infusion
arm group label: UB-221 (0.6 mg/kg)
arm group type: Experimental
description: Intravenous infusion
arm group label: UB-221 (2 mg/kg)
arm group type: Experimental
description: Intravenous infusion
arm group label: UB-221 (6 mg/kg)
arm group type: Experimental
description: Intravenous infusion
arm group label: UB-221 (10 mg/kg)
arm group type: Experimental
description: Intravenous infusion
intervention type: Biological
intervention name: UB-221
description: UB-221 (75 mg/ml)
arm group label: UB-221 (0.2 mg/kg)
arm group label: UB-221 (0.6 mg/kg)
arm group label: UB-221 (10 mg/kg)
arm group label: UB-221 (2 mg/kg)
arm group label: UB-221 (6 mg/kg)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Urticaria
mesh term: Chronic Urticaria