<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/NCT04453618</url>
  </required_header>
  <id_info>
    <org_study_id>HA1403-CSP-002；V1.0</org_study_id>
    <nct_id>NCT04453618</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of SYHA1402 in Healthy Subjects</brief_title>
  <official_title>Safety, Tolerability, Pharmacokinetics, and Food Effect of a Tablet Formulation of SYHA1402 in Healthy Subjects: A Phase-1, Single Center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSPC ZhongQi Pharmaceutical Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSPC ZhongQi Pharmaceutical Technology 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>
      A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food&#xD;
      Effect) of SYHA1402 in Healthy Subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study consists of two parts: The objective of the food effect study (Part 1) is to&#xD;
      investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed&#xD;
      and fasted conditions following the oral administration of SYHA1402.&#xD;
&#xD;
      The primary objective of the multiple doses study (Part 2) is to investigate safety,&#xD;
      tolerability and Pharmacokinetics of SYHA1402 in healthy subjects following oral&#xD;
      administration of Multiple rising doses.&#xD;
&#xD;
      Secondary objectives are the exploration of pharmacokinetics (PK) following multiple oral&#xD;
      doses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of food on the pharmacokinetic(Cmax）</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions</time_frame>
    <description>Effect of food on the pharmacokinetic profile of SYHA1402 based on maximum observed plasma concentration (Cmax) (Part 1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of food on the pharmacokinetic(AUC0-inf）</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions</time_frame>
    <description>Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity) (Part 1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effect of food on the pharmacokinetic(AUC0-t）</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions</time_frame>
    <description>Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-t (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of last measurable concentration) (Part 1).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety and tolerability of multiple doses of SYHA1402 administered orally will be assessed (Part2).</measure>
    <time_frame>up to 5 days after the last dose</time_frame>
    <description>incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability of SYHA1402 administered orally in fed and fasted conditions will be assessed (Part1)</measure>
    <time_frame>up to 4 days after the last dose</time_frame>
    <description>incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-t(Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>Rate and Extent of Absorption SYHA1402 by Assessment of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC0-inf(Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>Rate and Extent of Absorption SYHA1402 by Assessment of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cmax(Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>Rate and Extent of Absorption SYHA1402 by Assessment of the maximum measured concentration of the analyte in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax(Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>Rate and Extent of Absorption SYHA1402 by Assessment of the Time to Reach Maximum Observed Concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2z(Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Terminal Elimination Half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F(Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Clearance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F(Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Volume of Distribution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rac(AUC)(Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>Rate and Extent of Absorption of SYHA1402 by Assessment of the Accumulation Ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rac(Cmax) (Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>Rate and Extent of Absorption of AZD7986 by Assessment of the Accumulation Ratio for Cmax</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The assessment of the dose-proportionality based on Cmax (Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>The assessment of the dose-proportionality in the plasma pharmacokinetics (Cmax) of SYHA1402</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The assessment of the dose-proportionality based on AUC (Part2)</measure>
    <time_frame>Predose and multiple timepoints up to 24 hours after the last dose</time_frame>
    <description>The assessment of the dose-proportionality in the plasma pharmacokinetics (AUC) of SYHA1402</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Diabetic Peripheral Neuropathy</condition>
  <arm_group>
    <arm_group_label>Food effect</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects receive a single dose of SYHA1402 (100mg) in either a fasted state or with a meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple doses 25mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects receive multiple doses of SYHA1402 (25mg) or Placebo(25mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple doses 50mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects receive multiple doses of SYHA1402 (50mg) or Placebo (50mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple doses 150mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Healthy subjects receive multiple doses of SYHA1402 (150mg) or Placebo (150mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FE-SYHA1402 100mg</intervention_name>
    <description>in either a fasted state or with a meal</description>
    <arm_group_label>Food effect</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SYHA1402-25mg</intervention_name>
    <description>SYHA1402 25mg, oral tablets</description>
    <arm_group_label>Multiple doses 25mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo-25mg</intervention_name>
    <description>Matching placebo tablets</description>
    <arm_group_label>Multiple doses 25mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SYHA1402-50mg</intervention_name>
    <description>SYHA1402 50mg, oral tablets</description>
    <arm_group_label>Multiple doses 50mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo-50mg</intervention_name>
    <description>Matching placebo tablets</description>
    <arm_group_label>Multiple doses 50mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SYHA1402-150mg</intervention_name>
    <description>SYHA1402 150mg, oral tablets</description>
    <arm_group_label>Multiple doses 150mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo-150mg</intervention_name>
    <description>Matching placebo tablets</description>
    <arm_group_label>Multiple doses 150mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy male or female subjects aged 18 to 45 years (inclusive).&#xD;
&#xD;
          2. Have a body mass index (BMI) between 19.0 and 26.0 kg/m2 inclusive and weigh at least&#xD;
             45.0 kg (female) or 50.0 kg (male) inclusive at screening.&#xD;
&#xD;
          3. With no clinically significant or relevant abnormalities as determined by medical&#xD;
             history, vital signs, physical examination, and clinical laboratory tests.&#xD;
&#xD;
          4. All subjects of reproductive potential must agree to use effective, non-hormonal&#xD;
             contraceptive measures (such as condoms, intrauterine devices without drugs) from the&#xD;
             signing of informed consent to 3 months after the study. A subject is eligible to&#xD;
             participate if she/he is not a person of childbearing potential (had a bilateral&#xD;
             oophorectomy, bilateral salpingo-oophorectomy, or vasectomy). A male subject refrains&#xD;
             from donating sperm during the study period and for 3 months after the study.&#xD;
&#xD;
          5. Signed informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are pregnant or lactating.&#xD;
&#xD;
          2. History or current evidence of any clinically significant cardiac, endocrinologic,&#xD;
             hematologic, hepatobiliary, immunologic, metabolic, urologic, pulmonary, neurologic,&#xD;
             psychiatric, renal, or other major disease, as determined by the investigator.&#xD;
&#xD;
          3. Surgery history within six months before signing the informed consent;&#xD;
&#xD;
          4. Allergic history to more than one drug or other serious allergic history.&#xD;
&#xD;
          5. Any other abnormal findings on vital signs&#xD;
&#xD;
          6. Any clinically significant abnormalities in ECG: a QTc interval greater than 450 ms&#xD;
             (male) or 470 ms (female), or with a history of prolonged QTc interval;&#xD;
&#xD;
          7. Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody&#xD;
             (anti-HCV), Human immunodeficiency virus antibody (anti-HIV) or Treponema Pallidum&#xD;
             antibody (Anti-TP) at screening.&#xD;
&#xD;
          8. Use of drugs within 2 weeks before signing the informed consent, including&#xD;
             over-the-counter or prescription medication, including biological product, Chinese&#xD;
             traditional medicine, herbal medicine, vitamin dietary supplements, health care&#xD;
             products, oral or imbedded long-acting contraceptives.&#xD;
&#xD;
          9. Alcohol abuse or positive test for alcohol screening.&#xD;
&#xD;
         10. Smoker.&#xD;
&#xD;
         11. History or clinical evidence of drug abuse within the one years before screening, or&#xD;
             positive test for drug abuse at screening.&#xD;
&#xD;
         12. Use of too much caffeine in beverages, foods or in any form, which may interfere the&#xD;
             absorption, distribution, metabolism, or excretion of drugs, within 4 weeks before&#xD;
             signing informed consent&#xD;
&#xD;
         13. Loss of blood or blood donation more than 200 mL within 8 weeks before signing&#xD;
             informed consent, or plan on blood donation during the study period and 1 months after&#xD;
             the last dose of drug.&#xD;
&#xD;
         14. Have a surgical schedule or a plan on excessive physical activity during the study&#xD;
             period.&#xD;
&#xD;
         15. Subjects participating in other clinical trials, or who have participated in any other&#xD;
             clinical trials of drugs within three months before signing informed consent;&#xD;
&#xD;
         16. Not suitable for this trial as determined 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_contact>
    <last_name>Yanping Liu</last_name>
    <phone>0311-67808817</phone>
    <email>liuyanping@mail.ecspc.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 28, 2020</last_update_submitted>
  <last_update_submitted_qc>June 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</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>Peripheral Nervous System Diseases</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/NCT04453618
org study id: HA1403-CSP-002；V1.0
nct id: NCT04453618
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Multiple Doses Study to Evaluate the Safety, Tolerability, Pharmacokinetics (Including Food
      Effect) of SYHA1402 in Healthy Subjects.
This study consists of two parts: The objective of the food effect study (Part 1) is to
      investigate the effect of food on the pharmacokinetic profiles of SYHA1402 tablets under fed
      and fasted conditions following the oral administration of SYHA1402.

      The primary objective of the multiple doses study (Part 2) is to investigate safety,
      tolerability and Pharmacokinetics of SYHA1402 in healthy subjects following oral
      administration of Multiple rising doses.

      Secondary objectives are the exploration of pharmacokinetics (PK) following multiple oral
      doses.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Effect of food on the pharmacokinetic(Cmax）
time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
description: Effect of food on the pharmacokinetic profile of SYHA1402 based on maximum observed plasma concentration (Cmax) (Part 1).
measure: Effect of food on the pharmacokinetic(AUC0-inf）
time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
description: Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity) (Part 1).
measure: Effect of food on the pharmacokinetic(AUC0-t）
time frame: Predose and multiple timepoints up to 24 hours after the last dose in fed and fasted conditions
description: Effect of food on the pharmacokinetic profile of SYHA1402 based on AUC0-t (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of last measurable concentration) (Part 1).
measure: Safety and tolerability of multiple doses of SYHA1402 administered orally will be assessed (Part2).
time frame: up to 5 days after the last dose
description: incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
measure: Safety and tolerability of SYHA1402 administered orally in fed and fasted conditions will be assessed (Part1)
time frame: up to 4 days after the last dose
description: incidence and severity of adverse events (AEs), abnormalities in clinical laboratory assessments, ECGs, vital sign assessments, and physical exams
measure: AUC0-t(Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: Rate and Extent of Absorption SYHA1402 by Assessment of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point
measure: AUC0-inf(Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: Rate and Extent of Absorption SYHA1402 by Assessment of the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to infinity
measure: Cmax(Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: Rate and Extent of Absorption SYHA1402 by Assessment of the maximum measured concentration of the analyte in plasma
measure: Tmax(Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: Rate and Extent of Absorption SYHA1402 by Assessment of the Time to Reach Maximum Observed Concentration
measure: t1/2z(Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Terminal Elimination Half-life
measure: CL/F(Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Clearance
measure: Vz/F(Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: Rate and Extent of Absorption SYHA1402 by Assessment of the Apparent Volume of Distribution
measure: Rac(AUC)(Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: Rate and Extent of Absorption of SYHA1402 by Assessment of the Accumulation Ratio
measure: Rac(Cmax) (Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: Rate and Extent of Absorption of AZD7986 by Assessment of the Accumulation Ratio for Cmax
measure: The assessment of the dose-proportionality based on Cmax (Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: The assessment of the dose-proportionality in the plasma pharmacokinetics (Cmax) of SYHA1402
measure: The assessment of the dose-proportionality based on AUC (Part2)
time frame: Predose and multiple timepoints up to 24 hours after the last dose
description: The assessment of the dose-proportionality in the plasma pharmacokinetics (AUC) of SYHA1402
arm group label: Food effect
arm group type: Experimental
description: Healthy subjects receive a single dose of SYHA1402 (100mg) in either a fasted state or with a meal.
arm group label: Multiple doses 25mg
arm group type: Experimental
description: Healthy subjects receive multiple doses of SYHA1402 (25mg) or Placebo(25mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）.
arm group label: Multiple doses 50mg
arm group type: Experimental
description: Healthy subjects receive multiple doses of SYHA1402 (50mg) or Placebo (50mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）.
arm group label: Multiple doses 150mg
arm group type: Experimental
description: Healthy subjects receive multiple doses of SYHA1402 (150mg) or Placebo (150mg) for a total of 7 days (QD on Day1 and Day7, Q8h on Day2 to Day6）.
intervention type: Drug
intervention name: FE-SYHA1402 100mg
description: in either a fasted state or with a meal
arm group label: Food effect
intervention type: Drug
intervention name: SYHA1402-25mg
description: SYHA1402 25mg, oral tablets
arm group label: Multiple doses 25mg
intervention type: Drug
intervention name: Placebo-25mg
description: Matching placebo tablets
arm group label: Multiple doses 25mg
intervention type: Drug
intervention name: SYHA1402-50mg
description: SYHA1402 50mg, oral tablets
arm group label: Multiple doses 50mg
intervention type: Drug
intervention name: Placebo-50mg
description: Matching placebo tablets
arm group label: Multiple doses 50mg
intervention type: Drug
intervention name: SYHA1402-150mg
description: SYHA1402 150mg, oral tablets
arm group label: Multiple doses 150mg
intervention type: Drug
intervention name: Placebo-150mg
description: Matching placebo tablets
arm group label: Multiple doses 150mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yanping Liu
phone: 0311-67808817
email: liuyanping@mail.ecspc.com
responsible party type: Sponsor
mesh term: Peripheral Nervous System Diseases