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/NCT05968508</url>
    </required_header>
    <id_info>
      <org_study_id>BAT-1806-003-CR</org_study_id>
      <nct_id>NCT05968508</nct_id>
    </id_info>
    <brief_title>A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects</brief_title>
    <official_title>A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Bio-Thera Solutions</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Bio-Thera Solutions</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>
        This is a randomized, double-blind, single-dose, two-arm parallel study to compare the&#xD;
        pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with&#xD;
        RoActemra® (from EU) in healthy male subjects.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose&#xD;
        of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously.&#xD;
  &#xD;
        A 14-day screening period is set in this study. Subjects will be admitted one day prior to&#xD;
        administration (Day -1) and can be discharged only upon completion of relevant observations&#xD;
        and evaluations after administration on Day 5. After discharge, subjects need to return to&#xD;
        the hospital for 10 follow-ups as required in the study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">November 2023</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>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>AUC0-inf</measure>
      <time_frame>from Day0 to Day57</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>AUC0-t</measure>
      <time_frame>from Day0 to Day57</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Cmax</measure>
      <time_frame>from Day0 to Day57</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Healthy Men</condition>
    <arm_group>
      <arm_group_label>BAT1806 prefilled subcutaneous injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>RoActemra® (from EU)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)</intervention_name>
      <description>A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously.</description>
      <arm_group_label>BAT1806 prefilled subcutaneous injection</arm_group_label>
      <arm_group_label>RoActemra® (from EU)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects can be enrolled only when they meet all the following inclusion criteria:&#xD;
  &#xD;
                 1. Signed the informed consent form prior to the study, sufficient understanding of&#xD;
                    the content, procedure and possible adverse reactions of the study;&#xD;
  &#xD;
                 2. Willing and able to comply with the visit and treatment specified in the study;&#xD;
  &#xD;
                 3. Subjects (including their partners) who are willing to refrain from pregnancy,&#xD;
                    sperm donation and take effective contraceptive method in the future 6 months&#xD;
                    (i.e., 6 months after study medication), see Appendix 4 for the detailed&#xD;
                    contraceptive measures;&#xD;
  &#xD;
                 4. Healthy male subjects aged 18～55 years (inclusive);&#xD;
  &#xD;
                 5. BMI ranging from 18.0～28.0 kg/m2 (inclusive), and weight ranging from 55.0～85.0&#xD;
                    kg (inclusive);&#xD;
  &#xD;
                 6. Normal or abnormal physical examination that is judged as clinically&#xD;
                    insignificant;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects can not be enrolled in this study if any of the following criteria is met:&#xD;
  &#xD;
                 1. Smoking &gt;5 cigarettes per day within three months prior to the study;&#xD;
  &#xD;
                 2. Any serious allergic reaction to food or drug at present or in the past, or&#xD;
                    allergy to Tocilizumab, or serious allergy or allergic reaction to human,&#xD;
                    humanized or murine monoclonal antibody;&#xD;
  &#xD;
                 3. History of excessive drinking (14 units of alcohol per week: 1 unit = 285 mL&#xD;
                    beer, or 25 mL liquor, or 125 mL wine);&#xD;
  &#xD;
                 4. Blood donation or massive blood loss (&gt;450 mL) within three months prior to&#xD;
                    screening, or plan for blood donation or surgery during the study;&#xD;
  &#xD;
                 5. Intake of any prescription drug, over-the-counter drug, any vitamin product or&#xD;
                    herbal medicine within 28 days prior to screening;&#xD;
  &#xD;
                 6. Great change in dietary or exercise habit within 2 weeks prior to screening or&#xD;
                    from screening to administration;&#xD;
  &#xD;
                 7. Having any disease that may increase hemorrhagic risk, such as haemorrhoids with&#xD;
                    hemorrhagic symptoms, acute gastritis or gastric and duodenal ulcer;&#xD;
  &#xD;
                 8. Clinically significant abnormality in echocardiography;&#xD;
  &#xD;
                 9. Clinically significant abnormality in clinical laboratory examination, or other&#xD;
                    clinical findings showing the following disorders of clinical relevance&#xD;
                    (including but not limited to gastrointestinal, renal, hepatic, neurological,&#xD;
                    hematological, endocrine, oncological, pulmonary, immune, mental or cerebro- and&#xD;
                    cardiovascular diseases);&#xD;
  &#xD;
                10. Clinically significant (judged by investigators) abnormality in ECG, or QTcF &gt;&#xD;
                    450ms (allowed to be repeated for once, the subject needs to be excluded if the&#xD;
                    two measurements of QTcF are &gt; 450ms);&#xD;
  &#xD;
                11. Acute disease or concomitant medication from screening to prior to administration&#xD;
                    of study drug;&#xD;
  &#xD;
                12. Positive urine drug screen, or history of drug abuse or use of narcotics in the&#xD;
                    past 5 years;&#xD;
  &#xD;
                13. Positive HBsAg in five hepatitis B markers at screening; or positive anti-HBc and&#xD;
                    negative anti-HBs; or positive hepatitis C antibody; or positive HIV antibody; or&#xD;
                    positive Treponema pallidum antibody;&#xD;
  &#xD;
                14. Intake of any alcohol-containing product within 48 hours prior to dosing of study&#xD;
                    drug, or failure to limit alcohol consumption as required during the study;&#xD;
  &#xD;
                15. Currently or previously having malignant tumor;&#xD;
  &#xD;
                16. History of hypertension, or systolic blood pressure ≥ 140 mmHg, or diastolic&#xD;
                    blood pressure ≥90 mmHg at screening/baseline (allowed to be repeated for once,&#xD;
                    the subject needs to be excluded if the two measurements of systolic blood&#xD;
                    pressure ≥ 140 mmHg, or diastolic blood pressure ≥90 mmHg);&#xD;
  &#xD;
                17. Patients with hepatic disorder who are judged by investigators as inappropriate&#xD;
                    for enrollment;&#xD;
  &#xD;
                18. Presence of active infection, including acute and chronic infection as well as&#xD;
                    local infection;&#xD;
  &#xD;
                19. Chest X-ray showing active pulmonary tuberculosis; or previous history of&#xD;
                    tuberculosis or latent tuberculosis infection, or clinical manifestations&#xD;
                    suspected as tuberculosis (including but not limited to pulmonary tuberculosis);&#xD;
                    Positive for T-SPOT®.TB interferon-γ-release assays, or contact with patients&#xD;
                    with tuberculosis within three months or/and symptoms or/and signs suspected as&#xD;
                    tuberculosis;&#xD;
  &#xD;
                20. Had received or plan to receive live virus vaccine or immunosuppressant within 12&#xD;
                    weeks prior to administration of study drug;&#xD;
  &#xD;
                21. Having participated in drug clinical trial within three months prior to the first&#xD;
                    dose of study drug, or plan to participate in other drug clinical trial during&#xD;
                    the study;&#xD;
  &#xD;
                22. Those who are considered by investigators as inappropriate for enrollment.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wei Hu, Ph.D</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Second Hospital of Anhui Medical University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yueran Liu</last_name>
      <phone>18344566097</phone>
      <email>yrliu@bio-thera.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhaohe Wang, Ph.D</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Anhui Medical University</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wei Hu, Ph.D</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
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/NCT05968508
  org study id: BAT-1806-003-CR
  nct id: NCT05968508
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, double-blind, single-dose, two-arm parallel study to compare the
        pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with
        RoActemra® (from EU) in healthy male subjects.
  A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose
        of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously.
  
        A 14-day screening period is set in this study. Subjects will be admitted one day prior to
        administration (Day -1) and can be discharged only upon completion of relevant observations
        and evaluations after administration on Day 5. After discharge, subjects need to return to
        the hospital for 10 follow-ups as required in the study.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  measure: AUC0-inf
  time frame: from Day0 to Day57
  measure: AUC0-t
  time frame: from Day0 to Day57
  measure: Cmax
  time frame: from Day0 to Day57
  arm group label: BAT1806 prefilled subcutaneous injection
  arm group type: Experimental
  arm group label: RoActemra® (from EU)
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)
  description: A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously.
  arm group label: BAT1806 prefilled subcutaneous injection
  arm group label: RoActemra® (from EU)
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wei Hu, Ph.D
  role: Principal Investigator
  affiliation: The Second Hospital of Anhui Medical University
  last name: Yueran Liu
  phone: 18344566097
  email: yrliu@bio-thera.com
  last name: Zhaohe Wang, Ph.D
  facility: 
  contact: 
  country: China
  responsible party type: Sponsor