xml: <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/NCT06021574</url>
    </required_header>
    <id_info>
      <org_study_id>leadingpharm2019013</org_study_id>
      <nct_id>NCT06021574</nct_id>
    </id_info>
    <brief_title>A First-in-human Study of a Novel Recombinant Humanized Anti-interleukin-6 Receptor Monoclonal Antibody</brief_title>
    <official_title>A Single Center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial of a Novel Recombinant Humanized Anti Interleukin-6 Receptor Monoclonal Antibody in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Affiliated Hospital of Qingdao University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Beijing VDJBio Co., LTD.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>The Affiliated Hospital of Qingdao University</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 goal of this clinical trial is to study the tolerability, safety, pharmacokinetics and&#xD;
        immunogenicity of investigational drug in healthy subjects. The main questions it aims to&#xD;
        answer are:&#xD;
  &#xD;
          -  Safety and tolerability of investigational drug.&#xD;
  &#xD;
          -  pharmacokinetics and immunogenicity of investigational drug. Participants will receive a&#xD;
             single intravenous administration of investigational drug or placebo. Blood samples are&#xD;
             collected at specified time points.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 28, 2019</start_date>
    <completion_date type="Actual">January 6, 2020</completion_date>
    <primary_completion_date type="Actual">January 6, 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>adverse events</measure>
      <time_frame>up to 57 days</time_frame>
      <description>Incidence, severity and relation to investigational drugs of adverse events</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-AUC0-t</measure>
      <time_frame>up to 57 days</time_frame>
      <description>area under the concentration-time curve (AUC) from administration to the last measurable concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-AUC0-inf</measure>
      <time_frame>up to 57 days</time_frame>
      <description>AUC extrapolated to infinity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-Cmax</measure>
      <time_frame>up to 57 days</time_frame>
      <description>maximum serum concentration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-Tmax</measure>
      <time_frame>up to 57 days</time_frame>
      <description>time to Cmax</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-t1/2</measure>
      <time_frame>up to 57 days</time_frame>
      <description>elimination half-life</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-Vz</measure>
      <time_frame>up to 57 days</time_frame>
      <description>volume of distribution</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-CLz</measure>
      <time_frame>up to 57 days</time_frame>
      <description>clearance rate</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics- λz</measure>
      <time_frame>up to 57 days</time_frame>
      <description>elimination rate constant</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-MRT0-t</measure>
      <time_frame>up to 57 days</time_frame>
      <description>mean residence time (MRT) from administration to the last measurable concentration (MRT0-t)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-MRT0-inf</measure>
      <time_frame>up to 57 days</time_frame>
      <description>MRT extrapolated to infinity</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anti-Drug antibody (ADA)</measure>
      <time_frame>up to 57 days</time_frame>
      <description>Percentage of subjects tested ADA positive.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Neutralizing antibodies (Nab)</measure>
      <time_frame>up to 57 days</time_frame>
      <description>Percentage of subjects tested Nab positive.</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>A single intravenous administration of 1mg VDJ001 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: VDJ001 Drug: Placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>A single intravenous administration of 2mg VDJ001 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: VDJ001 Drug: Placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>A single intravenous administration of 4mg VDJ001 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: VDJ001 Drug: Placebo</description>
    </arm_group>
    <arm_group>
      <arm_group_label>A single intravenous administration of 8mg VDJ001 or placebo</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Drug: VDJ001 Drug: Placebo</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VDJ001</intervention_name>
      <description>a novel recombinant humanized anti-interleukin-6 receptor monoclonal antibody</description>
      <arm_group_label>A single intravenous administration of 1mg VDJ001 or placebo</arm_group_label>
      <arm_group_label>A single intravenous administration of 2mg VDJ001 or placebo</arm_group_label>
      <arm_group_label>A single intravenous administration of 4mg VDJ001 or placebo</arm_group_label>
      <arm_group_label>A single intravenous administration of 8mg VDJ001 or placebo</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo</description>
      <arm_group_label>A single intravenous administration of 1mg VDJ001 or placebo</arm_group_label>
      <arm_group_label>A single intravenous administration of 2mg VDJ001 or placebo</arm_group_label>
      <arm_group_label>A single intravenous administration of 4mg VDJ001 or placebo</arm_group_label>
      <arm_group_label>A single intravenous administration of 8mg VDJ001 or placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Sign the informed consent form and comply with the protocol to complete the study.&#xD;
  &#xD;
            2. Age ≥18 years old and ≤45 years old (at the date of signing the informed consent);&#xD;
               females weigh between 45.0~75.0kg, males weigh between 50.0~80.0kg, the body mass&#xD;
               index ( BMI) within the range of 19.0~26.0kg/m2.&#xD;
  &#xD;
            3. Function of heart, liver and kidney is normal.&#xD;
  &#xD;
            4. The blood pregnancy test for female of childbearing age is negative, and the&#xD;
               volunteers or their spouses use appropriate and effective contraceptive measures, such&#xD;
               as abstinence, intrauterine device and double barrier method from the test period to 6&#xD;
               months after administration of study drugs.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Allergic constitution (e.g. allergic to two or more drugs / foods).&#xD;
  &#xD;
            2. Those who have a clear history of malignant tumors, neurological or mental disorders&#xD;
               (including epilepsy or dementia), heart failure, or immunodeficiency or&#xD;
               immunosuppressive diseases, or have undergone major surgery within 6 months before&#xD;
               randomization.&#xD;
  &#xD;
            3. Those with severe bleeding factors that affect venous blood collection or those who&#xD;
               are unable/unwilling to receive venipuncture.&#xD;
  &#xD;
            4. Those who have received any vaccines within 6 months before randomization.&#xD;
  &#xD;
            5. Those who have previously received anti-IL-6 drugs or other monoclonal antibody&#xD;
               treatments, or have used any biological agents within 12 months before randomization.&#xD;
  &#xD;
            6. Those who have administered with other clinical trial drugs within 3 months before&#xD;
               randomization.&#xD;
  &#xD;
            7. Massive bleeding or whole blood or component blood (&gt; 400ml) donation within 3 months&#xD;
               before randomization.&#xD;
  &#xD;
            8. With active bacterial, viral, fungal, or parasitic infection or any infection that&#xD;
               requires systemic anti-infective treatment within 4 weeks before randomization.&#xD;
  &#xD;
            9. Those who have received any health products or treated by drugs (including&#xD;
               prescription drugs such as warfarin, cyclosporine, theophylline, simvastatin,&#xD;
               omeprazole, dextromethorphan, over-the-counter drugs, proprietary Chinese medicine,&#xD;
               vitamins, dietary supplements, etc.) within 3 months before randomization or those who&#xD;
               may receive drugs during the trial.&#xD;
  &#xD;
           10. Those who have used soft drugs (such as marijuana) within 3 months before&#xD;
               randomization or hard drugs (such as cocaine, phencyclidine, etc.) within 1 year&#xD;
               before the trial; or those with positive drug abuse test results (cocaine, marijuana,&#xD;
               morphine, amphetamine, methamphetamine, phencyclidine, benzodiazepines, barbiturates,&#xD;
               methadone and tricyclic antidepressants).&#xD;
  &#xD;
           11. Alcoholics or those who drink regularly within 3 months before randomization, or those&#xD;
               with a positive alcohol breath test.&#xD;
  &#xD;
           12. Those who smoke within 1 month before screening.&#xD;
  &#xD;
           13. Those with positive results of nicotine test during screening.&#xD;
  &#xD;
           14. Drinking excessive amounts of tea, coffee and/or caffeinated beverages every day.&#xD;
  &#xD;
           15. Positive results of γ interferon release test (T-SPOT).&#xD;
  &#xD;
           16. Positive result for any one of human immunodeficiency virus (HIV) antibody, treponema&#xD;
               pallidum antibody, hepatitis C virus antibody, hepatitis B surface antigen.&#xD;
  &#xD;
           17. Result of rheumatoid factor, anti-double-stranded DNA antibody, antinuclear antibody,&#xD;
               or anti-cyclic citrulline antibody test is abnormal with clinical significance.&#xD;
  &#xD;
           18. Those who plan to undergo surgery (including cosmetic surgery, dental surgery and oral&#xD;
               surgery) during the trial period; or those who plan to participate in strenuous&#xD;
               exercise (including physical contact exercise or collision exercise) during the trial&#xD;
               period.&#xD;
  &#xD;
           19. Those who schedule to donate blood during the trial period; or plan to receive any&#xD;
               biological drugs within 3 months after the administration of study drug or those who&#xD;
               plan to receive monoclonal antibody drugs within 9 months after the administration of&#xD;
               study drug.&#xD;
  &#xD;
           20. Those who plan to get pregnant, or to donate sperm or eggs within 6 months after the&#xD;
               administration of study drugs.&#xD;
  &#xD;
           21. Not suitable for enrollment or may not be able to complete the trial due to other&#xD;
               reasons determined by investigator.&#xD;
  &#xD;
           22. For females: be pregnant or lactating; had unprotected sex with their partner within&#xD;
               14 days before the trial; have taken oral contraceptives 30 days before the trial or&#xD;
               plan to take them during the trial; or have used or plan to use long-acting estrogen&#xD;
               or progesterone injections or implants within 6 months before the trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yu Cao</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Affiliated Hospital of Qingdao University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>the Affliated Hospital of Qingdao University</name>
        <address>
          <city>Qingdao</city>
          <state>Shandong</state>
          <zip>266000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The Affiliated Hospital of Qingdao University</investigator_affiliation>
      <investigator_full_name>Cao Yu</investigator_full_name>
      <investigator_title>Director of Clinical Trials Center of Affiliated Hospital of Qingdao University</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021574
  org study id: leadingpharm2019013
  nct id: NCT06021574
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to study the tolerability, safety, pharmacokinetics and
        immunogenicity of investigational drug in healthy subjects. The main questions it aims to
        answer are:
  
          -  Safety and tolerability of investigational drug.
  
          -  pharmacokinetics and immunogenicity of investigational drug. Participants will receive a
             single intravenous administration of investigational drug or placebo. Blood samples are
             collected at specified time points.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: adverse events
  time frame: up to 57 days
  description: Incidence, severity and relation to investigational drugs of adverse events
  measure: Pharmacokinetics-AUC0-t
  time frame: up to 57 days
  description: area under the concentration-time curve (AUC) from administration to the last measurable concentration
  measure: Pharmacokinetics-AUC0-inf
  time frame: up to 57 days
  description: AUC extrapolated to infinity
  measure: Pharmacokinetics-Cmax
  time frame: up to 57 days
  description: maximum serum concentration
  measure: Pharmacokinetics-Tmax
  time frame: up to 57 days
  description: time to Cmax
  measure: Pharmacokinetics-t1/2
  time frame: up to 57 days
  description: elimination half-life
  measure: Pharmacokinetics-Vz
  time frame: up to 57 days
  description: volume of distribution
  measure: Pharmacokinetics-CLz
  time frame: up to 57 days
  description: clearance rate
  measure: Pharmacokinetics- λz
  time frame: up to 57 days
  description: elimination rate constant
  measure: Pharmacokinetics-MRT0-t
  time frame: up to 57 days
  description: mean residence time (MRT) from administration to the last measurable concentration (MRT0-t)
  measure: Pharmacokinetics-MRT0-inf
  time frame: up to 57 days
  description: MRT extrapolated to infinity
  measure: Anti-Drug antibody (ADA)
  time frame: up to 57 days
  description: Percentage of subjects tested ADA positive.
  measure: Neutralizing antibodies (Nab)
  time frame: up to 57 days
  description: Percentage of subjects tested Nab positive.
  arm group label: A single intravenous administration of 1mg VDJ001 or placebo
  arm group type: Experimental
  description: Drug: VDJ001 Drug: Placebo
  arm group label: A single intravenous administration of 2mg VDJ001 or placebo
  arm group type: Experimental
  description: Drug: VDJ001 Drug: Placebo
  arm group label: A single intravenous administration of 4mg VDJ001 or placebo
  arm group type: Experimental
  description: Drug: VDJ001 Drug: Placebo
  arm group label: A single intravenous administration of 8mg VDJ001 or placebo
  arm group type: Experimental
  description: Drug: VDJ001 Drug: Placebo
  intervention type: Drug
  intervention name: VDJ001
  description: a novel recombinant humanized anti-interleukin-6 receptor monoclonal antibody
  arm group label: A single intravenous administration of 1mg VDJ001 or placebo
  arm group label: A single intravenous administration of 2mg VDJ001 or placebo
  arm group label: A single intravenous administration of 4mg VDJ001 or placebo
  arm group label: A single intravenous administration of 8mg VDJ001 or placebo
  intervention type: Drug
  intervention name: Placebo
  description: Placebo
  arm group label: A single intravenous administration of 1mg VDJ001 or placebo
  arm group label: A single intravenous administration of 2mg VDJ001 or placebo
  arm group label: A single intravenous administration of 4mg VDJ001 or placebo
  arm group label: A single intravenous administration of 8mg VDJ001 or placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yu Cao
  role: Principal Investigator
  affiliation: The Affiliated Hospital of Qingdao University
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: The Affiliated Hospital of Qingdao University
  investigator full name: Cao Yu
  investigator title: Director of Clinical Trials Center of Affiliated Hospital of Qingdao University
  sharing ipd: No