<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/NCT03758716</url>
  </required_header>
  <id_info>
    <org_study_id>FB825CLIIS-01-AD</org_study_id>
    <nct_id>NCT03758716</nct_id>
  </id_info>
  <brief_title>An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis</brief_title>
  <official_title>An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fountain Biopharma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fountain Biopharma Inc.</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>
      The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with&#xD;
      Atopic Dermatitis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-labeled exploratory study to evaluate safety and efficacy of FB825 in adults&#xD;
      with atopic dermatitis (AD). The study will be conduct at one medical center in Taiwan.&#xD;
&#xD;
      Approximately 12 subjects with atopic dermatitis (AD), who meet the criteria for study entry,&#xD;
      will be enrolled to the one-arm-study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 3, 2017</start_date>
  <completion_date type="Actual">September 19, 2019</completion_date>
  <primary_completion_date type="Actual">January 28, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>% Change From Baseline in Total IgE</measure>
    <time_frame>Day 169</time_frame>
    <description>Detect total IgE in serum by ImmunoCAP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>% Change From Baseline in Allergen-specific IgE</measure>
    <time_frame>Day 169</time_frame>
    <description>Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total IgE</measure>
    <time_frame>Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)</time_frame>
    <description>Detect total IgE in serum by ImmunoCAP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Change From Baseline in Allergen-specific IgE</measure>
    <time_frame>Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)</time_frame>
    <description>Detect specific IgE in serum by ImmunoCAP. (Dog dander)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Changes From Baseline in Irritability Visual Analogue Scale (VAS)</measure>
    <time_frame>Days 85</time_frame>
    <description>VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Changes From Baseline in Eczema Area and Severity Index (EASI)</measure>
    <time_frame>Day 85</time_frame>
    <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)</measure>
    <time_frame>Days 169</time_frame>
    <description>SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis</measure>
    <time_frame>Days 169</time_frame>
    <description>IGA measurement follow the normal by Principal Investigator, range from 0-4. The lower the scores the better situation of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis</measure>
    <time_frame>Days 169</time_frame>
    <description>BSA measurement follow the normal by Principal Investigator, range from 0-100. The lower the scores the better situation of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs)</measure>
    <time_frame>through study completion, an average of 1 year.</time_frame>
    <description>Safety will be assessed by monitoring and recording of adverse events (AEs) and serious adverse event (SAEs); physical examination findings and vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature), clinical laboratory test results (hematology, coagulation, serum chemistry [including liver function tests, blood glucose level], and urinalysis); 12-lead ECG results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Changes From Baseline in Eczema Area and Severity Index (EASI)</measure>
    <time_frame>Day 57</time_frame>
    <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Changes From Baseline in Eczema Area and Severity Index (EASI)</measure>
    <time_frame>Day 113</time_frame>
    <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Changes From Baseline in Eczema Area and Severity Index (EASI)</measure>
    <time_frame>Day 141</time_frame>
    <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% Changes From Baseline in Eczema Area and Severity Index (EASI)</measure>
    <time_frame>Day 169</time_frame>
    <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>FB825</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FB825, FB825-15D11, Anti-CemX</intervention_name>
    <description>Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
    <arm_group_label>FB825</arm_group_label>
    <other_name>FB825-15D11, Lot # 16-2056</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects between 20 and 65 years of age, inclusive.&#xD;
&#xD;
          2. The subject has a physician-confirmed diagnosis of chronic atopic dermatitis based on&#xD;
             3 years history of symptoms defined by the Eichenfield revised criteria of Hannifin&#xD;
             and Rajka and supported by positive allergen-specific IgE at the screening visit.&#xD;
&#xD;
          3. Eczema Area and Severity Index (EASI) score ≧14 at the screening and baseline visits.&#xD;
&#xD;
          4. Investigator's Global Assessment (IGA) score ≧ 3 (5-point scale) at the screening and&#xD;
             baseline visits.&#xD;
&#xD;
          5. ≧10 % body surface area (BSA) of AD involvement at the screening and baseline visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are pregnant or lactating.&#xD;
&#xD;
          2. The subject is on diet or with poor intake.&#xD;
&#xD;
          3. The subject has a history of heart arrhythmias (any clinically relevant).&#xD;
&#xD;
          4. The subject has a positive test result for hepatitis B surface antigen, hepatitis C&#xD;
             virus antibody, or human immunodeficiency virus types 1 and 2 antibodies at screening.&#xD;
&#xD;
          5. The subject has a history of alcohol or drug abuse that would impair or risk the&#xD;
             patients' full participation in the study, in the opinion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chia-Yu Chu, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <results_first_submitted>January 8, 2021</results_first_submitted>
  <results_first_submitted_qc>February 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 15, 2021</results_first_posted>
  <last_update_submitted>April 20, 2021</last_update_submitted>
  <last_update_submitted_qc>April 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</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>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 2, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT03758716/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>FB825</title>
          <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FB825</title>
          <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.75" spread="6.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Taiwan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total IgE</title>
          <description>Total IgE (immunoglobulin E)</description>
          <units>IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6611.53" spread="6693.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>EASI Scores</title>
          <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.98" spread="8.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>% Change From Baseline in Total IgE</title>
        <description>Detect total IgE in serum by ImmunoCAP.</description>
        <time_frame>Day 169</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Change From Baseline in Total IgE</title>
          <description>Detect total IgE in serum by ImmunoCAP.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-45.57" spread="21.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>% Change From Baseline in Allergen-specific IgE</title>
        <description>Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)</description>
        <time_frame>Day 169</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Change From Baseline in Allergen-specific IgE</title>
          <description>Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-50.16" spread="23.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total IgE</title>
        <description>Detect total IgE in serum by ImmunoCAP.</description>
        <time_frame>Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total IgE</title>
          <description>Detect total IgE in serum by ImmunoCAP.</description>
          <units>IU/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1 Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="482.93" spread="1528.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 1 Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-137.70" spread="1634.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 1 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-298.07" spread="1874.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-862.73" spread="1934.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1956.86" spread="2880.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 92</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1581.65" spread="2253.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 99</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1419.49" spread="2901.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 113</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1968.97" spread="2668.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 141</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2350.48" spread="3023.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 169/ EOS (end of study)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2817.01" spread="3708.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Change From Baseline in Allergen-specific IgE</title>
        <description>Detect specific IgE in serum by ImmunoCAP. (Dog dander)</description>
        <time_frame>Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Change From Baseline in Allergen-specific IgE</title>
          <description>Detect specific IgE in serum by ImmunoCAP. (Dog dander)</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dose 1 Day 8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.88" spread="12.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 1 Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-5.81" spread="17.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 1 Day 29</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.83" spread="21.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 1 Day 57</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-22.38" spread="20.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.44" spread="15.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 92</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-33.22" spread="17.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 99</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-36.30" spread="17.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 113</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.02" spread="16.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 141</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.07" spread="16.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dose 2 Day 169/ EOS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.94" spread="15.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Changes From Baseline in Irritability Visual Analogue Scale (VAS)</title>
        <description>VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient.</description>
        <time_frame>Days 85</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Changes From Baseline in Irritability Visual Analogue Scale (VAS)</title>
          <description>VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-32.57" spread="30.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
        <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
        <time_frame>Day 85</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
          <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-44.33" spread="41.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)</title>
        <description>SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient.</description>
        <time_frame>Days 169</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)</title>
          <description>SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-56.19" spread="15.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis</title>
        <description>IGA measurement follow the normal by Principal Investigator, range from 0-4. The lower the scores the better situation of the patient.</description>
        <time_frame>Days 169</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis</title>
          <description>IGA measurement follow the normal by Principal Investigator, range from 0-4. The lower the scores the better situation of the patient.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-39.58" spread="19.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis</title>
        <description>BSA measurement follow the normal by Principal Investigator, range from 0-100. The lower the scores the better situation of the patient.</description>
        <time_frame>Days 169</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis</title>
          <description>BSA measurement follow the normal by Principal Investigator, range from 0-100. The lower the scores the better situation of the patient.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-60.04" spread="26.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs)</title>
        <description>Safety will be assessed by monitoring and recording of adverse events (AEs) and serious adverse event (SAEs); physical examination findings and vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature), clinical laboratory test results (hematology, coagulation, serum chemistry [including liver function tests, blood glucose level], and urinalysis); 12-lead ECG results.</description>
        <time_frame>through study completion, an average of 1 year.</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
        <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
        <time_frame>Day 57</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
          <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-68.09" spread="29.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
        <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
        <time_frame>Day 113</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
          <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-70.00" spread="34.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
        <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
        <time_frame>Day 141</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
          <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-73.12" spread="25.32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
        <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
        <time_frame>Day 169</time_frame>
        <group_list>
          <group group_id="O1">
            <title>FB825</title>
            <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
          </group>
        </group_list>
        <measure>
          <title>% Changes From Baseline in Eczema Area and Severity Index (EASI)</title>
          <description>EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.</description>
          <units>percentage change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-72.14" spread="20.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>169 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>FB825</title>
          <description>Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.&#xD;
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Herpes simplex</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Scratch</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Electrocardiogram QT prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>NienYi Chen PhD</name_or_title>
      <organization>Oneness Biotech Co., Ltd.</organization>
      <phone>+886 2 2655 8687 ext 613</phone>
      <email>nienyichen@onenessbio.com.tw</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03758716
org study id: FB825CLIIS-01-AD
nct id: NCT03758716
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with
      Atopic Dermatitis
This is an open-labeled exploratory study to evaluate safety and efficacy of FB825 in adults
      with atopic dermatitis (AD). The study will be conduct at one medical center in Taiwan.

      Approximately 12 subjects with atopic dermatitis (AD), who meet the criteria for study entry,
      will be enrolled to the one-arm-study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: % Change From Baseline in Total IgE
time frame: Day 169
description: Detect total IgE in serum by ImmunoCAP.
measure: % Change From Baseline in Allergen-specific IgE
time frame: Day 169
description: Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)
measure: Change From Baseline in Total IgE
time frame: Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)
description: Detect total IgE in serum by ImmunoCAP.
measure: % Change From Baseline in Allergen-specific IgE
time frame: Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)
description: Detect specific IgE in serum by ImmunoCAP. (Dog dander)
measure: % Changes From Baseline in Irritability Visual Analogue Scale (VAS)
time frame: Days 85
description: VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient.
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
time frame: Day 85
description: EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
measure: % Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)
time frame: Days 169
description: SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient.
measure: % Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis
time frame: Days 169
description: IGA measurement follow the normal by Principal Investigator, range from 0-4. The lower the scores the better situation of the patient.
measure: % Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis
time frame: Days 169
description: BSA measurement follow the normal by Principal Investigator, range from 0-100. The lower the scores the better situation of the patient.
measure: Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs)
time frame: through study completion, an average of 1 year.
description: Safety will be assessed by monitoring and recording of adverse events (AEs) and serious adverse event (SAEs); physical examination findings and vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature), clinical laboratory test results (hematology, coagulation, serum chemistry [including liver function tests, blood glucose level], and urinalysis); 12-lead ECG results.
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
time frame: Day 57
description: EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
time frame: Day 113
description: EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
time frame: Day 141
description: EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
measure: % Changes From Baseline in Eczema Area and Severity Index (EASI)
time frame: Day 169
description: EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
arm group label: FB825
arm group type: Experimental
description: Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.
intervention type: Drug
intervention name: FB825, FB825-15D11, Anti-CemX
description: Pharmaceutical form: 20mg/ml solution Route of administration: IV
arm group label: FB825
other name: FB825-15D11, Lot # 16-2056
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chia-Yu Chu, MD-PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 