<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/NCT03255993</url>
  </required_header>
  <id_info>
    <org_study_id>SPH3127-102</org_study_id>
    <nct_id>NCT03255993</nct_id>
  </id_info>
  <brief_title>The Tolerability and Pharmacokinetics of Multiple Doses of SPH3127 in Chinese Healthy People</brief_title>
  <official_title>Multiple Doses Study to Evaluate the Tolerability and Pharmacokinetics of SPH3127 in Chinese Healthy People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Pharmaceuticals Holding Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Pharmaceuticals Holding Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</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 study was a single center, parallel, randomized, double blind, placebo-controlled phase&#xD;
      Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127&#xD;
      tablet in healthy subjects by increasing multiple dosing&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Three panels(100mg, 200mg, 400mg), each consisting of eight participants (The number of&#xD;
      individual subjects in each group was not less than 1/3 of the total number).Participants&#xD;
      begin to receive the first dose of SPH3127 100mg. Then Participants begin to receive the&#xD;
      second dose of SPH3127 200mg,after the researchers confirmed that the 100mg dose group was&#xD;
      safe and well tolerated.Then the third dose of SPH3127 400mg must wait for the result of the&#xD;
      second dose's safety and tolerability. If the subjects during escalating dose to the biggest&#xD;
      tolerate dose group were not well tolerated, the study must adjust the maximum dose group and&#xD;
      fall to a low dose group to conduct another test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">September 20, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with adverse events (AEs)</measure>
    <time_frame>Baseline to 13-16 days post last dose</time_frame>
    <description>to assess incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH3127</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plasma area under curve (AUC)(0-∞) of SPH3127</measure>
    <time_frame>10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7; 10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6</time_frame>
    <description>to evaluate Plasma AUC(0-∞) of SPH3127</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in laboratory hematology values</measure>
    <time_frame>Baseline to 13-16 days post last dose</time_frame>
    <description>to evaluate the Change from baseline in laboratory hematology values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in laboratory chemistry values</measure>
    <time_frame>Baseline to 13-16 days post last dose</time_frame>
    <description>to evaluate the Change from baseline in laboratory chemistry values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in laboratory urinalysis values</measure>
    <time_frame>Baseline to 13-16 days post last dose</time_frame>
    <description>to evaluate the Change from baseline in laboratory urinalysis values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in ECG</measure>
    <time_frame>Baseline to 13-16 days post last dose</time_frame>
    <description>to evaluate the Change from baseline in ECG</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Plasma Concentration (Cmax) of SPH3127</measure>
    <time_frame>10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6</time_frame>
    <description>to evaluate Plasma Cmax of SPH3127</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Maximum time to peak (Tmax) of SPH3127</measure>
    <time_frame>10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6</time_frame>
    <description>to evaluate Plasma Tmax of SPH3127</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent terminal half-life of SPH3127</measure>
    <time_frame>10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6</time_frame>
    <description>to evaluate terminal half-life of SPH3127</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>SPH3127 100mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of SPH3127 50 mg*2 qd *7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to SPH3127 100mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single dose of placebo matching to SPH3127 50mg*2 qd *7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPH3127 200mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of SPH3127 100 mg*2 qd *7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to SPH3127 200mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single dose of placebo matching to SPH3127 100mg*2 qd *7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SPH3127 400mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single dose of SPH3127 100 mg*4 qd *7 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo to SPH3127 400mg</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>A single dose of placebo matching to SPH3127 100mg*4 qd *7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPH3127 50mg</intervention_name>
    <description>SPH3127 50mg</description>
    <arm_group_label>SPH3127 100mg</arm_group_label>
    <other_name>SPH3127 is a new study drug for hypertension</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SPH3127 100mg</intervention_name>
    <description>SPH3127 100mg</description>
    <arm_group_label>SPH3127 200mg</arm_group_label>
    <arm_group_label>SPH3127 400mg</arm_group_label>
    <other_name>SPH3127 is a new study drug for hypertension</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo matching to SPH3127 50mg</intervention_name>
    <description>Placebo matching to SPH3127 50mg</description>
    <arm_group_label>Placebo to SPH3127 100mg</arm_group_label>
    <other_name>Placebo is oral tablet to matching to SPH3127 50mg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo matching to SPH3127 100mg</intervention_name>
    <description>Placebo matching to SPH3127 100mg</description>
    <arm_group_label>Placebo to SPH3127 200mg</arm_group_label>
    <arm_group_label>Placebo to SPH3127 400mg</arm_group_label>
    <other_name>Placebo is oral tablet to matching to SPH3127 50mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The body mass index is 18-28kg/m2 (including the critical value), which allows the&#xD;
             minimum weight of men to be 50kg (including the critical value) and 45kg for women&#xD;
             (including the critical value).&#xD;
&#xD;
          2. Before the study,participant has know about the significance , potential benefits,&#xD;
             inconveniences and potential risks of the study&#xD;
&#xD;
          3. Participant has understood the research's procedure and sign the informed consent .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant who are Pregnancy, lactating women, and planned trials begin within six&#xD;
             months of pregnancy&#xD;
&#xD;
          -  Participant who has abnormal Physical examination, laboratory examination results and&#xD;
             clinical significance (such as: liver function examination - aspartate&#xD;
             aminotransferase (AST) and alanine aminotransferase (ALT) more than 1.5 times that of&#xD;
             the upper limit of normal)&#xD;
&#xD;
          -  Participant who has a history of cardiovascular, liver, kidney, digestive tract,&#xD;
             nervous system, blood system, familial hematologic disease, abnormal thyroid function,&#xD;
             or mental abnormality&#xD;
&#xD;
          -  Participant who has drug allergy history and anaphylactic reaction&#xD;
&#xD;
          -  Participant who took oral contraceptive in 6 months&#xD;
&#xD;
          -  Participant who used any drug (including Chinese herbal medicine) within 1 week.&#xD;
&#xD;
          -  Participant who donated blood within 2 months&#xD;
&#xD;
          -  Participant who participated clinical trials of any drug in 3 months (as subjects)&#xD;
&#xD;
          -  Participant who has any positive result of virus serology check: human&#xD;
             immunodeficiency virus antigen antibody (HIV Ag/Ab) and hepatitis c virus (HCV) -&#xD;
             immunoglobulin G(IgG) antibody to IgG, hepatitis b surface antigen (HBsAg) and&#xD;
             treponema pallidum antibody (TP)&#xD;
&#xD;
          -  Participant who are used to smoke, alcohol abuse, eat coffee and strong tea and drug&#xD;
             abuse&#xD;
&#xD;
          -  Participant who the researchers believe that there are volunteers who are not suitable&#xD;
             for the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The capital medical university affiliated Beijing anzhen hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>November 11, 2021</last_update_submitted>
  <last_update_submitted_qc>November 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2021</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>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT03255993
org study id: SPH3127-102
nct id: NCT03255993
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was a single center, parallel, randomized, double blind, placebo-controlled phase
      Ib clinical trial to to evaluate the safety and tolerability and pharmacokinetics of SPH3127
      tablet in healthy subjects by increasing multiple dosing
Three panels(100mg, 200mg, 400mg), each consisting of eight participants (The number of
      individual subjects in each group was not less than 1/3 of the total number).Participants
      begin to receive the first dose of SPH3127 100mg. Then Participants begin to receive the
      second dose of SPH3127 200mg,after the researchers confirmed that the 100mg dose group was
      safe and well tolerated.Then the third dose of SPH3127 400mg must wait for the result of the
      second dose's safety and tolerability. If the subjects during escalating dose to the biggest
      tolerate dose group were not well tolerated, the study must adjust the maximum dose group and
      fall to a low dose group to conduct another test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of participants with adverse events (AEs)
time frame: Baseline to 13-16 days post last dose
description: to assess incidence and intensity of Adverse Events according to Common Toxicity Criteria (CTC version 4.03) associated with increasing doses of SPH3127
measure: Plasma area under curve (AUC)(0-∞) of SPH3127
time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7; 10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
description: to evaluate Plasma AUC(0-∞) of SPH3127
measure: Change from baseline in laboratory hematology values
time frame: Baseline to 13-16 days post last dose
description: to evaluate the Change from baseline in laboratory hematology values
measure: Change from baseline in laboratory chemistry values
time frame: Baseline to 13-16 days post last dose
description: to evaluate the Change from baseline in laboratory chemistry values
measure: Change from baseline in laboratory urinalysis values
time frame: Baseline to 13-16 days post last dose
description: to evaluate the Change from baseline in laboratory urinalysis values
measure: Change from baseline in ECG
time frame: Baseline to 13-16 days post last dose
description: to evaluate the Change from baseline in ECG
measure: Maximum Plasma Concentration (Cmax) of SPH3127
time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
description: to evaluate Plasma Cmax of SPH3127
measure: Plasma Maximum time to peak (Tmax) of SPH3127
time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
description: to evaluate Plasma Tmax of SPH3127
measure: Apparent terminal half-life of SPH3127
time frame: 10 minutes predose, 0.17hour, 0.33hour, 0.5hour, 0.75hour, 1hour, 1.25hour, 1.5hour, 2hour, 4hour, 6hour, 8hour, 12hour postdose at Day 1 and 7;10 minutes predose at Day 2; 10 minutes predose, 1hour postdose at Day 5 or 6
description: to evaluate terminal half-life of SPH3127
arm group label: SPH3127 100mg
arm group type: Experimental
description: A single dose of SPH3127 50 mg*2 qd *7 days
arm group label: Placebo to SPH3127 100mg
arm group type: Placebo Comparator
description: A single dose of placebo matching to SPH3127 50mg*2 qd *7 days
arm group label: SPH3127 200mg
arm group type: Experimental
description: A single dose of SPH3127 100 mg*2 qd *7 days
arm group label: Placebo to SPH3127 200mg
arm group type: Placebo Comparator
description: A single dose of placebo matching to SPH3127 100mg*2 qd *7 days
arm group label: SPH3127 400mg
arm group type: Experimental
description: A single dose of SPH3127 100 mg*4 qd *7 days
arm group label: Placebo to SPH3127 400mg
arm group type: Placebo Comparator
description: A single dose of placebo matching to SPH3127 100mg*4 qd *7 days
intervention type: Drug
intervention name: SPH3127 50mg
description: SPH3127 50mg
arm group label: SPH3127 100mg
other name: SPH3127 is a new study drug for hypertension
intervention type: Drug
intervention name: SPH3127 100mg
description: SPH3127 100mg
arm group label: SPH3127 200mg
arm group label: SPH3127 400mg
other name: SPH3127 is a new study drug for hypertension
intervention type: Drug
intervention name: Placebo matching to SPH3127 50mg
description: Placebo matching to SPH3127 50mg
arm group label: Placebo to SPH3127 100mg
other name: Placebo is oral tablet to matching to SPH3127 50mg
intervention type: Drug
intervention name: Placebo matching to SPH3127 100mg
description: Placebo matching to SPH3127 100mg
arm group label: Placebo to SPH3127 200mg
arm group label: Placebo to SPH3127 400mg
other name: Placebo is oral tablet to matching to SPH3127 50mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Hypertension