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/NCT05983289</url>
    </required_header>
    <id_info>
      <org_study_id>HSK7653-101</org_study_id>
      <nct_id>NCT05983289</nct_id>
    </id_info>
    <brief_title>Single Escalating Dose Study Of HSK7653 In Healthy Subjects</brief_title>
    <official_title>A Single Center, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Escalating Doses Of HSK7653 In Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Haisco Pharmaceutical Group Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Haisco Pharmaceutical Group 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>
        To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD)&#xD;
        characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify&#xD;
        the metabolites of HSK7653 in healthy adult subjects&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 8, 2018</start_date>
    <completion_date type="Actual">July 3, 2019</completion_date>
    <primary_completion_date type="Actual">July 3, 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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAEs)</measure>
      <time_frame>First dose of study drug up to 29 days after last dose of study drug</time_frame>
      <description>Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Area Under the Curve From Time Zero to Last Quantifiable Concentration</measure>
      <time_frame>Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;</time_frame>
      <description>Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Maximum Observed Plasma Concentration (Cmax)</measure>
      <time_frame>Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;</time_frame>
      <description>Maximum Observed Plasma Concentration (Cmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Reach Maximum Observed Plasma Concentration (Tmax)</measure>
      <time_frame>Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;</time_frame>
      <description>Time to Reach Maximum Observed Plasma Concentration (Tmax)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plasma Decay Half-Life (t1/2)</measure>
      <time_frame>Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;</time_frame>
      <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration</measure>
      <time_frame>Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;</time_frame>
      <description>Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">62</enrollment>
    <condition>T2DM (Type 2 Diabetes Mellitus)</condition>
    <arm_group>
      <arm_group_label>HSK7653</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single dose, oral</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Single dose, oral</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HSK7653</intervention_name>
      <description>HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg</description>
      <arm_group_label>HSK7653</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Matching placebo tables in six doses beginning at 5 mg and rising to 150 mg</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 and Age ≤60 years&#xD;
  &#xD;
            -  BMI ≥18 and BMI ≤ 25 kg/m2 (Body Mass Index)&#xD;
  &#xD;
            -  Able to understand the procedures of the study, provide written informed consent, and&#xD;
               be willing to comply with the protocol of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any finding of the medical examination (physical examination, laboratory examination,&#xD;
               12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical&#xD;
               relevance during screening&#xD;
  &#xD;
            -  Evidence or history of clinically significant renal, gastrointestinal (including&#xD;
               pancreatitis), hepatic disease at the time of screening&#xD;
  &#xD;
            -  Has a positive result on screening for serum hepatitis B surface antigen (HBsAg),&#xD;
               hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human&#xD;
               immunodeficiency virus (HIV)&#xD;
  &#xD;
            -  Treatment with an investigational drug within 3 months&#xD;
  &#xD;
            -  Fertile male subjects who are unwilling or unable to use a highly effective method of&#xD;
               contraception for the duration of the study and for at least 6 months after the last&#xD;
               dose&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hongzhong Liu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100032</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</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>Diabetes Mellitus, Type 2</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05983289
  org study id: HSK7653-101
  nct id: NCT05983289
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD)
        characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify
        the metabolites of HSK7653 in healthy adult subjects
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
  time frame: First dose of study drug up to 29 days after last dose of study drug
  description: Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.
  measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration
  time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
  description: Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
  measure: Maximum Observed Plasma Concentration (Cmax)
  time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
  description: Maximum Observed Plasma Concentration (Cmax)
  measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
  time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
  description: Time to Reach Maximum Observed Plasma Concentration (Tmax)
  measure: Plasma Decay Half-Life (t1/2)
  time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
  description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  measure: Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration
  time frame: Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration;
  description: Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration
  arm group label: HSK7653
  arm group type: Experimental
  description: Single dose, oral
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Single dose, oral
  intervention type: Drug
  intervention name: HSK7653
  description: HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg
  arm group label: HSK7653
  intervention type: Drug
  intervention name: Placebo
  description: Matching placebo tables in six doses beginning at 5 mg and rising to 150 mg
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Hongzhong Liu
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Diabetes Mellitus, Type 2
  sharing ipd: No