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/NCT06014736</url>
    </required_header>
    <id_info>
      <org_study_id>XJ101-I</org_study_id>
      <nct_id>NCT06014736</nct_id>
    </id_info>
    <brief_title>A Phase I Study of XJ101 in Chinese Healthy Subjects</brief_title>
    <official_title>A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of XJ101 in Chinese Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Starmab biologics（Shanghai）Co,.ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Starmab biologics（Shanghai）Co,.ltd</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized, double-blind, placebo-parallel intervention clinical study that will&#xD;
        include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects&#xD;
        will be assigned to one of four different dosage cohorts. Subjects in each cohort will&#xD;
        randomly be given experimental drug or a placebo.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">April 29, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 18, 2024</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Any adverse events that occurred among all subjects during the clinical trial, including clinical symptoms, vital signs or physical examination abnormalities, laboratory tests or 12-lead electrocardiogram abnormalities.</measure>
      <time_frame>From the time of informed consent through 92 days post dose.</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last])</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Observed Serum Concentration (Cmax)</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal Phase Elimination Half-life (t1/2)</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Elimination Rate Constant (Kel)</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean Residence Time (MRT)</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Serum Clearance (CL)</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apparent Volume of Distribution (Vd)</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Area Under the Serum Concentration Time Curve That Has Been Derived After Extrapolation (AUC_% Extrap)</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anti Drug Antibody (ADA) Assessments - Serum</measure>
      <time_frame>From Day 1 through 92 days post dose.</time_frame>
      <description>ADA responses to XJ101</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">38</enrollment>
    <condition>Staphylococcus Aureus Bloodstream Infection</condition>
    <arm_group>
      <arm_group_label>XJ101 for Injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>XJ101 via intravenous(IV).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo via intravenous(IV).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>XJ101 for Injection</intervention_name>
      <description>XJ101 is a recombinant humanized single domain antibody-Fc (human immunoglobulin G1 type) fusion protein.</description>
      <arm_group_label>XJ101 for Injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Placebo contains only excipients.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18 through 45 years at screening.&#xD;
  &#xD;
            2. Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, and body mass index (BMI) within the&#xD;
               range of 19.0 to 26.0 kg/m2 (including critical values).&#xD;
  &#xD;
            3. The subjects have no pregnancy plan and voluntarily avoid pregnancy from signing the&#xD;
               informed consent form until the end of the trail.&#xD;
  &#xD;
            4. Healthy on the basis of physical examination and medical and surgical history and&#xD;
               twelve-lead electrocardiogram (ECG) without clinically relevant abnormalities.&#xD;
  &#xD;
            5. Written informed consent and any locally required authorization (eg, HIPAA) obtained&#xD;
               from the subject prior to performing any protocol-related procedures, including&#xD;
               screening evaluations.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects with any abnormalities of respiratory system, circulatory system, digestive&#xD;
               system, nervous system, skeletal muscle system, blood and lymphatic system, immune&#xD;
               system and endocrine system.&#xD;
  &#xD;
            2. History of allergy to drugs or biological products.&#xD;
  &#xD;
            3. Acute infection within 4 weeks prior to study entry.&#xD;
  &#xD;
            4. Suffer from diseases caused by Staphylococcus aureus within one year, such as&#xD;
               bacteremia, sepsis and pyemia.&#xD;
  &#xD;
            5. Receipt of any standard vaccine within 4 weeks prior to investigational product dosing&#xD;
               or plan to vaccinate during the study period.&#xD;
  &#xD;
            6. Receipt of any major surgery within 3 months prior to the start of the trial, or have&#xD;
               not recovered from surgery, or plan to have a surgical during the trial.&#xD;
  &#xD;
            7. Those who cannot tolerate venipuncture, or have a history of injector and blood&#xD;
               sickness, or are not suitable for venous blood collection.&#xD;
  &#xD;
            8. Subjects with a history of drug abuse or drug use, or those with positive urine drug&#xD;
               screening.&#xD;
  &#xD;
            9. Blood donation or massive blood loss (&gt; 200 mL) within three months prior to screening&#xD;
               or plan to donate blood, receive blood transfusions, or use blood products during the&#xD;
               trial period or within 1 month after the end of the trial.&#xD;
  &#xD;
           10. Pregnant or lactating women.&#xD;
  &#xD;
           11. Use of any prescription drugs, over-the-counter drugs, vitamin products or herbal&#xD;
               medicines within 14 days prior to screening.&#xD;
  &#xD;
           12. Smoke more than 5 cigarettes per day within three months prior to screening&#xD;
  &#xD;
           13. Frequent drinkers in the three months before screening, i.e. those who drink more than&#xD;
               or equal to 14 units of alcohol per week on average (1 unit=17.7 ml ethanol, 1&#xD;
               unit=354 ml beer with 5% alcohol, 44.25 ml spirits with 40% alcohol, or 147.5 ml wine&#xD;
               with 12% alcohol), or those who do not agree to ban alcohol during the study period.&#xD;
  &#xD;
           14. Evidence of infection with HBV, hepatitis C, HIV, or syphilis.&#xD;
  &#xD;
           15. Positive alcohol breath test.&#xD;
  &#xD;
           16. Subjects with special dietary requirements and cannot accept a unified diet.&#xD;
  &#xD;
           17. Participation in other clinical trials within three months prior to enrollment or plan&#xD;
               to participate in other clinical trials during this period.&#xD;
  &#xD;
           18. Any other factors evaluated by investigators that patients cannot be enrolled.&#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>Ding xueying</last_name>
      <role>Study Director</role>
      <affiliation>Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sun yufang</last_name>
      <phone>+86 15137415798</phone>
      <email>sunyufang@starmabbio.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</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>Sepsis</mesh_term>
    </condition_browse>
    <!-- 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/NCT06014736
  org study id: XJ101-I
  nct id: NCT06014736
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, double-blind, placebo-parallel intervention clinical study that will
        include approximately 38 healthy subjects based on inclusion and exclusion criteria. Subjects
        will be assigned to one of four different dosage cohorts. Subjects in each cohort will
        randomly be given experimental drug or a placebo.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: Any adverse events that occurred among all subjects during the clinical trial, including clinical symptoms, vital signs or physical examination abnormalities, laboratory tests or 12-lead electrocardiogram abnormalities.
  time frame: From the time of informed consent through 92 days post dose.
  measure: Area Under the Serum Concentration Time Curve from Time Zero to Infinity (AUC [0-Infinity])
  time frame: From Day 1 through 92 days post dose.
  measure: Area Under the Serum Concentration Time Curve from Time Zero to Last Measurable Concentration (AUC [0-Last])
  time frame: From Day 1 through 92 days post dose.
  measure: Maximum Observed Serum Concentration (Cmax)
  time frame: From Day 1 through 92 days post dose.
  measure: Terminal Phase Elimination Half-life (t1/2)
  time frame: From Day 1 through 92 days post dose.
  measure: Elimination Rate Constant (Kel)
  time frame: From Day 1 through 92 days post dose.
  measure: Mean Residence Time (MRT)
  time frame: From Day 1 through 92 days post dose.
  measure: Apparent Serum Clearance (CL)
  time frame: From Day 1 through 92 days post dose.
  measure: Apparent Volume of Distribution (Vd)
  time frame: From Day 1 through 92 days post dose.
  measure: Percentage of Area Under the Serum Concentration Time Curve That Has Been Derived After Extrapolation (AUC_% Extrap)
  time frame: From Day 1 through 92 days post dose.
  measure: Anti Drug Antibody (ADA) Assessments - Serum
  time frame: From Day 1 through 92 days post dose.
  description: ADA responses to XJ101
  arm group label: XJ101 for Injection
  arm group type: Experimental
  description: XJ101 via intravenous(IV).
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Placebo via intravenous(IV).
  intervention type: Drug
  intervention name: XJ101 for Injection
  description: XJ101 is a recombinant humanized single domain antibody-Fc (human immunoglobulin G1 type) fusion protein.
  arm group label: XJ101 for Injection
  intervention type: Drug
  intervention name: Placebo
  description: Placebo contains only excipients.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Ding xueying
  role: Study Director
  affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  last name: Sun yufang
  phone: +86 15137415798
  email: sunyufang@starmabbio.com
  responsible party type: Sponsor
  mesh term: Sepsis