<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/NCT03804749</url>
  </required_header>
  <id_info>
    <org_study_id>LC00-043</org_study_id>
    <nct_id>NCT03804749</nct_id>
  </id_info>
  <brief_title>Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Study to Evaluate the Tolerance and Pharmacokinetics of Suramin Sodium in Healthy Chinese Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangdong Kangda Pharmaceutical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>First Affiliated Hospital of Zhejiang 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>
      This is a randomized, double-blind, placebo-controlled, single-dose with three incremental&#xD;
      doses, Phase 1 study to evaluate the tolerance and pharmacokinetics of suramin sodium for&#xD;
      injection in Chinese healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 36 subjects are divided into three dosage groups: 10mg/kg, 15mg/kg and 20mg/kg, in&#xD;
      which 20mg/kg is the conventional dosage per international pharmacopoeias for established&#xD;
      indications of suramin sodium. Each dose group contains 12 subjects. By randomization, 10 of&#xD;
      them receive suramin sodium while 2 of them receive placebo (0.9% sodium chloride injection）.&#xD;
      The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg)&#xD;
      and high dose (20mg/kg) groups, only after the safety in the previous dose group has been&#xD;
      demonstrated.&#xD;
&#xD;
      All subjects in each dose group will be un-blinded after blood/urine collection and safety&#xD;
      evaluation on Day 28. After that, blood and urine samples on suramin-dosing subjects will&#xD;
      continue to collect on Days 56、84、112 and 140.&#xD;
&#xD;
      Subjects receiving placebo will complete the study on Day 28 if no AE is observed, or follow&#xD;
      up till the adverse event (AE) return to normal or stabilize if AE is detected.&#xD;
&#xD;
      Blood and urine samples will be tested by a validated LC/MS method for pharmacokinetic study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Anticipated">December 19, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 19, 2019</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, Care Provider, Investigator)</masking>
    <masking_description>Double blind, placebo control</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>[ Day 1 to Day 140 ]</time_frame>
    <description>Adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the area under the plasma concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUC0-t) of suramin sodium</measure>
    <time_frame>[ Day 1 to Day 140 after study drug administration ]</time_frame>
    <description>Pharmacokinetics parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the AUC from time zero to infinity (AUC0-inf) of suramin sodium</measure>
    <time_frame>[ Day 1 to Day 140 after study drug administration ]</time_frame>
    <description>Pharmacokinetics parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>maximum plasma concentration (Cmax ) of suramin sodium</measure>
    <time_frame>[ Day 1 to Day 140 after study drug administration ]</time_frame>
    <description>Pharmacokinetics parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>half life （t1/2） of suramin sodium</measure>
    <time_frame>[Day 1 to Day 140 after study drug administration ]</time_frame>
    <description>Pharmacokinetics parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clearance （CL） of suramin sodium</measure>
    <time_frame>[ Day 1 to Day 140 after study drug administration ]</time_frame>
    <description>Pharmacokinetics parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>apparent volume of distribution（Vd） of suramin sodium</measure>
    <time_frame>[ Day 1 to Day 140 after study drug administration ]</time_frame>
    <description>Pharmacokinetics parameters</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the amount of drug excreted into the urine from time zero to time 7 days（Ae0-t） of suramin sodium</measure>
    <time_frame>[ Day 1 to Day 7 after study drug administration ]</time_frame>
    <description>Pharmacokinetics parameters</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Hand, Foot and Mouth Disease</condition>
  <arm_group>
    <arm_group_label>Group 1-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dose of suramin sodium is 10 mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 1-2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo is 0.9% sodium chloride injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dose of suramin sodium is 15mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2-2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo is 0.9% sodium chloride injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3-1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The dose of suramin sodium is 20mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3-2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The placebo is 0.9% sodium chloride injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>suramin sodium</intervention_name>
    <description>The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.。</description>
    <arm_group_label>Group 1-1</arm_group_label>
    <arm_group_label>Group 2-1</arm_group_label>
    <arm_group_label>Group 3-1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Placebo is 0.9% sodium chloride injection.</description>
    <arm_group_label>Group 1-2</arm_group_label>
    <arm_group_label>Group 2-2</arm_group_label>
    <arm_group_label>Group 3-2</arm_group_label>
    <other_name>0.9% sodium chloride injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy volunteers who fully understand the purpose, content, benefits and possible&#xD;
             adverse reactions of the test and voluntarily sign written informed consent prior to&#xD;
             the commencement of any test-related activities.&#xD;
&#xD;
          2. Healthy males or females, aged 18 to 45 years (including 18 and 45 years).&#xD;
&#xD;
          3. Male subjects weighed 50-75 kg (including 50 and 75 kg), female subjects weighed 45-75&#xD;
             kg (including 45 and 75 kg), body mass index (BMI) was 18.0-26.0 kg/m2 (including 18.0&#xD;
             and 26.0 kg/m2), where BMI = body weight (kg)/height2 (m2).&#xD;
&#xD;
          4. Have the ability to communicate with investigator and abide by the management&#xD;
             regulations of the hospital and the clinical research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Fail in physical examination, vital signs measurement, standard 12-lead&#xD;
             electrocardiogram, chest X-ray, laboratory examination [blood routine, urine routine,&#xD;
             blood biochemistry, blood coagulation function, infectious diseases, blood pregnancy&#xD;
             (only for women of childbearing age), as judged by the investigator to be of clinical&#xD;
             significance.&#xD;
&#xD;
          2. With gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung,&#xD;
             immunity, mental or cardiovascular diseases.&#xD;
&#xD;
          3. Has allergic constitution (allergic to two or more substances), or allergic history,&#xD;
             or known allergic to suramin sodium.&#xD;
&#xD;
          4. Cannot tolerate venipuncture and/or have a history of fainting blood or needle.&#xD;
&#xD;
          5. Has massive blood loss (&gt; 400 mL) or had donated blood/blood components within the&#xD;
             first six months of screening, or who planned to donate blood/blood components during&#xD;
             the study period.&#xD;
&#xD;
          6. Had participated in clinical trials of drugs and took research drugs within three&#xD;
             months before screening.&#xD;
&#xD;
          7. Smoke more than five cigarettes a day (including nicotine substitutes) or the same&#xD;
             amount of tobacco products in the first three months of screening.&#xD;
&#xD;
          8. Has history of drug abuse within 5 years before screening, or those who had used drugs&#xD;
             within 3 months before screening.&#xD;
&#xD;
          9. Has a history of alcoholism or moderate alcoholism in the first two years of screening&#xD;
             (moderate alcoholism is defined as drinking more than 3 units per day or 21 units per&#xD;
             week; a bottle of 350 mL beer, 120 mL white wine, 150 mL wine or 30 mL spirits is one&#xD;
             unit).&#xD;
&#xD;
         10. Pregnant or lactating women, or subjects (or their partners) who have pregnancy plans&#xD;
             during the trial and within three months after the end of the study, or who do not&#xD;
             agree to use non-drug contraceptive measures during the trial.&#xD;
&#xD;
         11. Positive urine drug screening in screening stage.&#xD;
&#xD;
         12. Alcohol urine positive in screening stage.&#xD;
&#xD;
         13. Nicotine positive in screening stage.&#xD;
&#xD;
         14. With acute diseases in screening period.&#xD;
&#xD;
         15. Had used any prescription, over-the-counter, vitamin products or Chinese herbal&#xD;
             medicines within 14 days before enrollment.&#xD;
&#xD;
         16. Female subjects of childbearing age who did not take non-drug contraceptive measures&#xD;
             within 14 days before admission.&#xD;
&#xD;
         17. Not suitable for participating into the trial as judged by the investigator.&#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>First Affiliated Hospital Zhejiang University</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianzhong Shentu, Ph.D.（Pharm）</last_name>
    <phone>0571 87236560</phone>
    <email>stjz@zju.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Affiliated Hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianzhong Shentu, Ph.D.（Pharm）</last_name>
      <phone>0571 87236560</phone>
      <email>stjz@zju.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 11, 2019</last_update_submitted>
  <last_update_submitted_qc>January 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Zhejiang University</investigator_affiliation>
    <investigator_full_name>shentu jianzhong</investigator_full_name>
    <investigator_title>Ph.D.（Pharm）</investigator_title>
  </responsible_party>
  <keyword>suramin sodium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Foot-and-Mouth Disease</mesh_term>
    <mesh_term>Hand, Foot and Mouth Disease</mesh_term>
    <mesh_term>Mouth Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suramin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03804749
org study id: LC00-043
nct id: NCT03804749
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This is a randomized, double-blind, placebo-controlled, single-dose with three incremental
      doses, Phase 1 study to evaluate the tolerance and pharmacokinetics of suramin sodium for
      injection in Chinese healthy adults.
A total of 36 subjects are divided into three dosage groups: 10mg/kg, 15mg/kg and 20mg/kg, in
      which 20mg/kg is the conventional dosage per international pharmacopoeias for established
      indications of suramin sodium. Each dose group contains 12 subjects. By randomization, 10 of
      them receive suramin sodium while 2 of them receive placebo (0.9% sodium chloride injection）.
      The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg)
      and high dose (20mg/kg) groups, only after the safety in the previous dose group has been
      demonstrated.

      All subjects in each dose group will be un-blinded after blood/urine collection and safety
      evaluation on Day 28. After that, blood and urine samples on suramin-dosing subjects will
      continue to collect on Days 56、84、112 and 140.

      Subjects receiving placebo will complete the study on Day 28 if no AE is observed, or follow
      up till the adverse event (AE) return to normal or stabilize if AE is detected.

      Blood and urine samples will be tested by a validated LC/MS method for pharmacokinetic study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Double blind, placebo control
measure: Number of subjects with adverse events
time frame: [ Day 1 to Day 140 ]
description: Adverse events
measure: the area under the plasma concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUC0-t) of suramin sodium
time frame: [ Day 1 to Day 140 after study drug administration ]
description: Pharmacokinetics parameters
measure: the AUC from time zero to infinity (AUC0-inf) of suramin sodium
time frame: [ Day 1 to Day 140 after study drug administration ]
description: Pharmacokinetics parameters
measure: maximum plasma concentration (Cmax ) of suramin sodium
time frame: [ Day 1 to Day 140 after study drug administration ]
description: Pharmacokinetics parameters
measure: half life （t1/2） of suramin sodium
time frame: [Day 1 to Day 140 after study drug administration ]
description: Pharmacokinetics parameters
measure: clearance （CL） of suramin sodium
time frame: [ Day 1 to Day 140 after study drug administration ]
description: Pharmacokinetics parameters
measure: apparent volume of distribution（Vd） of suramin sodium
time frame: [ Day 1 to Day 140 after study drug administration ]
description: Pharmacokinetics parameters
measure: the amount of drug excreted into the urine from time zero to time 7 days（Ae0-t） of suramin sodium
time frame: [ Day 1 to Day 7 after study drug administration ]
description: Pharmacokinetics parameters
arm group label: Group 1-1
arm group type: Experimental
description: The dose of suramin sodium is 10 mg/kg
arm group label: Group 1-2
arm group type: Placebo Comparator
description: The placebo is 0.9% sodium chloride injection
arm group label: Group 2-1
arm group type: Experimental
description: The dose of suramin sodium is 15mg/kg
arm group label: Group 2-2
arm group type: Placebo Comparator
description: The placebo is 0.9% sodium chloride injection
arm group label: Group 3-1
arm group type: Experimental
description: The dose of suramin sodium is 20mg/kg
arm group label: Group 3-2
arm group type: Placebo Comparator
description: The placebo is 0.9% sodium chloride injection
intervention type: Drug
intervention name: suramin sodium
description: The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.。
arm group label: Group 1-1
arm group label: Group 2-1
arm group label: Group 3-1
intervention type: Other
intervention name: placebo
description: Placebo is 0.9% sodium chloride injection.
arm group label: Group 1-2
arm group label: Group 2-2
arm group label: Group 3-2
other name: 0.9% sodium chloride injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: First Affiliated Hospital Zhejiang University
role: Principal Investigator
affiliation: First Affiliated Hospital of Zhejiang University
last name: Jianzhong Shentu, Ph.D.（Pharm）
phone: 0571 87236560
email: stjz@zju.edu.cn
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Zhejiang University
investigator full name: shentu jianzhong
investigator title: Ph.D.（Pharm）
mesh term: Foot-and-Mouth Disease
mesh term: Hand, Foot and Mouth Disease
mesh term: Mouth Diseases
mesh term: Suramin
sharing ipd: No