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/NCT06010537</url>
    </required_header>
    <id_info>
      <org_study_id>YHT-I-03</org_study_id>
      <nct_id>NCT06010537</nct_id>
    </id_info>
    <brief_title>Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle</brief_title>
    <official_title>A Single-center, Randomized, Open-label, Single-dose Study of Polysaccharide Superparamagnetic Iron Oxide Injection in Healthy Subjects to Evaluate Magnetic Resonance Imaging in Multiple Dose Groups</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a contrast-enhanced magnetic resonance imaging (MRI) study conducted on a&#xD;
        single-administration of polyglucose superparamagnetic iron oxide injection. Two dose groups&#xD;
        are set up in this study, 2.5 mg/kg and 3 mg/kg, and two subjects in each group received the&#xD;
        test drug for safety evaluation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 28, 2021</start_date>
    <completion_date type="Actual">April 30, 2021</completion_date>
    <primary_completion_date type="Actual">April 30, 2021</primary_completion_date>
    <phase>Early 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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse event rate</measure>
      <time_frame>Baseline up to 144 hours</time_frame>
      <description>The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Contrast-enhanced magnetic resonance angiography (CE-MRA)</measure>
      <time_frame>Before administration, 5 minutes, 12 hours, 24 hours, 36 hours, 48 hours after administration.</time_frame>
      <description>CE-MRA of the whole heart and large arteries, coronary angiography and contrast-enhanced scan of the upper abdomen, the aorta and its main branches (left and right renal arteries, celiac trunk, superior mesenteric arteries, bilateral iliac arteries) as well as bilateral femoral arteries of the lower limbs will be evaluated</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">4</enrollment>
    <condition>Magnetic Resonance Imaging</condition>
    <arm_group>
      <arm_group_label>polyglucose superparamagnetic iron oxide injection 2.5 mg/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intravenous injected polysaccharide superparamagnetic iron oxide injection at 2.5 mg/kg dose;</description>
    </arm_group>
    <arm_group>
      <arm_group_label>polyglucose superparamagnetic iron oxide injection 3.0 mg/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intravenous injected polysaccharide superparamagnetic iron oxide injection at 3.0 mg/kg dose;</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>polysaccharide superparamagnetic iron oxide injection</intervention_name>
      <description>Polysaccharide superparamagnetic iron oxide injection is a magnetic resonance contrast agent.</description>
      <arm_group_label>polyglucose superparamagnetic iron oxide injection 2.5 mg/kg</arm_group_label>
      <arm_group_label>polyglucose superparamagnetic iron oxide injection 3.0 mg/kg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Signing the informed consent form before the trial and fully understanding the&#xD;
               content, process and possible adverse effects of the trial;&#xD;
  &#xD;
            -  Be able to complete the study according to the requirements of the trial protocol;&#xD;
  &#xD;
            -  Male subjects aged 18 to 40 years old (including the threshold);&#xD;
  &#xD;
            -  Subjects weighing no less than 50 kilograms. Body mass index (BMI) = weight&#xD;
               (kg)/height2 (m2), BMI within the range of 19~26 (including the critical value);&#xD;
  &#xD;
            -  Health status: no mental abnormality, no history of cardiovascular system, nervous&#xD;
               system, respiratory system, digestive system, urinary system, endocrine system and&#xD;
               metabolic abnormalities;&#xD;
  &#xD;
            -  Vital signs, physical examination, laboratory tests, electrocardiogram and imaging&#xD;
               tests are normal or abnormal without clinical significance;&#xD;
  &#xD;
            -  No pregnancy and voluntary use of effective contraception for at least 6 months from 2&#xD;
               weeks prior to dosing to the last use of the study drug.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previously suffered from neuropsychiatric, respiratory, cardiovascular,&#xD;
               gastrointestinal, hematologic-lymphatic, hepatic or renal insufficiency, endocrine, or&#xD;
               musculoskeletal disorders, or other diseases, and in the judgment of the investigator,&#xD;
               the previous medical history may have an impact on the magnetic resonance imaging&#xD;
               procedure, the quality of the images, or the safety of the subject;&#xD;
  &#xD;
            -  Subjects with internal metal foreign bodies (dentures, contraceptive rings, metal&#xD;
               implants, metal clips, etc.) and persons who are claustrophobic;&#xD;
  &#xD;
            -  Those who are allergic to the study drug, its metabolites or its excipients;&#xD;
  &#xD;
            -  Subjects who have smoked more than 5 cigarettes per day for 3 months prior to the&#xD;
               trial;&#xD;
  &#xD;
            -  History of drug and/or alcohol abuse (14 units of alcohol per week: 1 unit = 360 ml of&#xD;
               beer or 45 ml of spirits of 40% alcohol or 150 ml of wine);&#xD;
  &#xD;
            -  Blood donation or significant blood loss (&gt; 450 ml) within 2 months prior to dosing;&#xD;
  &#xD;
            -  Use of any drug that alters liver enzyme activity (e.g., liver enzyme inhibitors&#xD;
               chlorpromazine, cimetidine, ciprofloxacin, metronidazole, etc.; liver enzyme inducers&#xD;
               barbiturates, carbamazepine, rifampicin, dexamethasone, etc.) in the 28 days prior to&#xD;
               dosing;&#xD;
  &#xD;
            -  Use of any prescription medication, over-the-counter medication, any vitamin product&#xD;
               or herbal remedy within 14 days prior to dosing;&#xD;
  &#xD;
            -  The need to use tobacco, alcohol and caffeinated beverages, or certain foods that may&#xD;
               affect metabolism (e.g., grapefruit, grapefruit juice, etc.) during the trial period,&#xD;
               or a significant change in dietary or exercise habits prior to the trial, or any other&#xD;
               factor that affects the absorption, distribution, metabolism, or excretion of the&#xD;
               drug;&#xD;
  &#xD;
            -  Use of an investigational drug or participation in a clinical trial of a drug within 2&#xD;
               months prior to dosing;&#xD;
  &#xD;
            -  Screening positive for hepatitis (including hepatitis B and C) and for AIDS and&#xD;
               syphilis;&#xD;
  &#xD;
            -  Screening positive for drugs or a history of drug abuse within the past 5 years or&#xD;
               drug use within the 3 months prior to the trial;&#xD;
  &#xD;
            -  Persons who have difficulty with MRI scanning or who cannot tolerate MRI scanning;&#xD;
  &#xD;
            -  Acute illness occurring during the pre-study screening phase or prior to study drug&#xD;
               administration;&#xD;
  &#xD;
            -  Subjects who are unable or incapable of complying with ward regulations.&#xD;
  &#xD;
            -  The subject is unable to complete the trial for personal reasons.&#xD;
  &#xD;
            -  Other circumstances which, in the judgment of the investigator, make enrollment in the&#xD;
               study unsuitable.&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Xinxiang Central Hospital</name>
        <address>
          <city>Xinxiang</city>
          <state>Henan</state>
          <zip>453000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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/NCT06010537
  org study id: YHT-I-03
  nct id: NCT06010537
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a contrast-enhanced magnetic resonance imaging (MRI) study conducted on a
        single-administration of polyglucose superparamagnetic iron oxide injection. Two dose groups
        are set up in this study, 2.5 mg/kg and 3 mg/kg, and two subjects in each group received the
        test drug for safety evaluation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Adverse event rate
  time frame: Baseline up to 144 hours
  description: The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
  measure: Contrast-enhanced magnetic resonance angiography (CE-MRA)
  time frame: Before administration, 5 minutes, 12 hours, 24 hours, 36 hours, 48 hours after administration.
  description: CE-MRA of the whole heart and large arteries, coronary angiography and contrast-enhanced scan of the upper abdomen, the aorta and its main branches (left and right renal arteries, celiac trunk, superior mesenteric arteries, bilateral iliac arteries) as well as bilateral femoral arteries of the lower limbs will be evaluated
  arm group label: polyglucose superparamagnetic iron oxide injection 2.5 mg/kg
  arm group type: Experimental
  description: Intravenous injected polysaccharide superparamagnetic iron oxide injection at 2.5 mg/kg dose;
  arm group label: polyglucose superparamagnetic iron oxide injection 3.0 mg/kg
  arm group type: Experimental
  description: Intravenous injected polysaccharide superparamagnetic iron oxide injection at 3.0 mg/kg dose;
  intervention type: Drug
  intervention name: polysaccharide superparamagnetic iron oxide injection
  description: Polysaccharide superparamagnetic iron oxide injection is a magnetic resonance contrast agent.
  arm group label: polyglucose superparamagnetic iron oxide injection 2.5 mg/kg
  arm group label: polyglucose superparamagnetic iron oxide injection 3.0 mg/kg
  criteria: 
  gender: Male
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: China
  responsible party type: Sponsor