<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/NCT04504448</url>
  </required_header>
  <id_info>
    <org_study_id>HNC664-101</org_study_id>
    <nct_id>NCT04504448</nct_id>
  </id_info>
  <brief_title>A Study of HNC664 in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Sequential Parallel Group, Single Ascending Doses (SAD) Study Following Oral Administration in Healthy Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of HNC664</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Henovcom Bioscience Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Henovcom Bioscience Co. Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD&#xD;
      after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food&#xD;
      effect will be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2020</start_date>
  <completion_date type="Actual">July 13, 2021</completion_date>
  <primary_completion_date type="Actual">July 13, 2021</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events and concomitant medications</measure>
    <time_frame>Between screening and 7-9 days after the last dose</time_frame>
    <description>To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with vital sign measurements</measure>
    <time_frame>Between screening and 7-9 days after the last dose</time_frame>
    <description>To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal vital signs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with clinical laboratory test results</measure>
    <time_frame>Between screening and 7-9 days after the last dose</time_frame>
    <description>To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal clinical laboratory test results</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with 12-lead ECGs</measure>
    <time_frame>Between screening and 7-9 days after the last dose</time_frame>
    <description>To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal 12-lead ECGs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with physical examinations</measure>
    <time_frame>Between screening and 7-9 days after the last dose</time_frame>
    <description>To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal physical examinations</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>HNC664 capsules</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HNC664 capsules,single ascending doses Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HNC664 placebos</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>HNC664 placebos,single ascending doses Single dose</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HNC664 capsules FED</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>HNC664 capsules,food effect,Single dose</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HNC664 capsules Single dose</intervention_name>
    <description>HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg</description>
    <arm_group_label>HNC664 capsules</arm_group_label>
    <other_name>HNC664 capsules</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HNC664 placebos Single dose</intervention_name>
    <description>HNC664 placebos single ascending doses,PO,Single dose, matching placebo</description>
    <arm_group_label>HNC664 placebos</arm_group_label>
    <other_name>HNC664 placebos</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>HNC664 capsules FED</intervention_name>
    <description>HNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC）</description>
    <arm_group_label>HNC664 capsules FED</arm_group_label>
    <other_name>HNC664 capsules</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteer, age 18-65 years&#xD;
&#xD;
          -  BMI between 18-32 kg/m2,and body weight not less than 50.0kg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition that might interfere with the procedures or tests in this study&#xD;
&#xD;
          -  Drug or alcohol abuse&#xD;
&#xD;
          -  Smoking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pharmaron</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 24, 2022</last_update_submitted>
  <last_update_submitted_qc>August 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2022</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>


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/NCT04504448
org study id: HNC664-101
nct id: NCT04504448
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this First-in-Human study is to evaluate the safety , tolerability，PK and PD
      after single ascending of HNC664 given to healthy subjects, compared to placebo. Also, food
      effect will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of subjects with adverse events and concomitant medications
time frame: Between screening and 7-9 days after the last dose
description: To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of AEs and CMs.
measure: Number of subjects with vital sign measurements
time frame: Between screening and 7-9 days after the last dose
description: To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal vital signs
measure: Number of subjects with clinical laboratory test results
time frame: Between screening and 7-9 days after the last dose
description: To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal clinical laboratory test results
measure: Number of subjects with 12-lead ECGs
time frame: Between screening and 7-9 days after the last dose
description: To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal 12-lead ECGs
measure: Number of subjects with physical examinations
time frame: Between screening and 7-9 days after the last dose
description: To evaluate the safety and tolerability of HNC664 in comparison with placebo after a single oral dose in healthy subjects in terms of abnormal physical examinations
arm group label: HNC664 capsules
arm group type: Experimental
description: HNC664 capsules,single ascending doses Single dose
arm group label: HNC664 placebos
arm group type: Placebo Comparator
description: HNC664 placebos,single ascending doses Single dose
arm group label: HNC664 capsules FED
arm group type: Experimental
description: HNC664 capsules,food effect,Single dose
intervention type: Drug
intervention name: HNC664 capsules Single dose
description: HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg
arm group label: HNC664 capsules
other name: HNC664 capsules
intervention type: Drug
intervention name: HNC664 placebos Single dose
description: HNC664 placebos single ascending doses,PO,Single dose, matching placebo
arm group label: HNC664 placebos
other name: HNC664 placebos
intervention type: Drug
intervention name: HNC664 capsules FED
description: HNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC）
arm group label: HNC664 capsules FED
other name: HNC664 capsules
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor