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/NCT06033742</url>
    </required_header>
    <id_info>
      <org_study_id>HS-10374-101</org_study_id>
      <nct_id>NCT06033742</nct_id>
    </id_info>
    <brief_title>A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects</brief_title>
    <official_title>A Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HS-10374 in Healthy Subjects</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu Hansoh Pharmaceutical Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu Hansoh Pharmaceutical 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>
        The purpose of this first-in-human study is to evaluate the safety, tolerability, and&#xD;
        pharmacokinetics (PK) of HS-10374 in healthy subjects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 13, 2021</start_date>
    <completion_date type="Actual">March 24, 2023</completion_date>
    <primary_completion_date type="Actual">March 24, 2023</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>Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation</measure>
      <time_frame>Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with clinical laboratory abnormalities</measure>
      <time_frame>Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)</time_frame>
      <description>Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with abnormalities of vital signs</measure>
      <time_frame>Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)</time_frame>
      <description>Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with abnormalities of physical examination</measure>
      <time_frame>Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)</time_frame>
      <description>Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with abnormalities of electrocardiogram (ECG) parameters</measure>
      <time_frame>Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)</time_frame>
      <description>ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cmax</measure>
      <time_frame>Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)</time_frame>
      <description>Maximum plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tmax</measure>
      <time_frame>Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)</time_frame>
      <description>Time to reach Cmax</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AUC</measure>
      <time_frame>Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)</time_frame>
      <description>Area under the plasma concentration-time curve</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>t½</measure>
      <time_frame>Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)</time_frame>
      <description>Terminal half-life</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CL/F</measure>
      <time_frame>Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)</time_frame>
      <description>Apparent clearance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vz/F</measure>
      <time_frame>Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)</time_frame>
      <description>Apparent volume of distribution</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rac</measure>
      <time_frame>Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)</time_frame>
      <description>Accumulation ratio</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">84</enrollment>
    <condition>Psoriasis</condition>
    <arm_group>
      <arm_group_label>HS-10374</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Single and multiple ascending doses of HS-10374 orally</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Single and multiple ascending doses of HS-10374-matched placebo orally</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HS-10374 tablets</intervention_name>
      <description>Single or multiple dosing of HS-10374 orally in a fasting state</description>
      <arm_group_label>HS-10374</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HS-10374-matched placebo tablets</intervention_name>
      <description>Single or multiple dosing of HS-10374-matched placebo orally in a fasting state</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy male or female subjects between the ages of 18-45 years&#xD;
  &#xD;
            2. Have no reproductive potential; or agree to use a highly effective method of&#xD;
               contraception, and refrain from donating sperm or eggs during the study period and for&#xD;
               at least 6 months after last dosing&#xD;
  &#xD;
            3. Have signed the informed consent form approved by the IRB&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Have a clinically significant infection currently or within past 30 days, or have a&#xD;
               history of active tuberculosis; or have positive screening test for infectious&#xD;
               disease, including tuberculosis, viral hepatitis, AIDS and syphilis&#xD;
  &#xD;
            2. Have a history of or current allergic disease&#xD;
  &#xD;
            3. Have a history of drug or alcohol abuse or currently positive test result(s) for&#xD;
               alcohol or drugs of abuse&#xD;
  &#xD;
            4. Smokers smoked ≥5 cigarettes per day within past 3 months or have a positive test&#xD;
               result for nicotine&#xD;
  &#xD;
            5. Clinically significant abnormal physical examination, vital signs, clinical laboratory&#xD;
               values, ECGs or imaging tests&#xD;
  &#xD;
            6. Pregnant or breastfeeding female subjects&#xD;
  &#xD;
            7. Have received hormone-based contraceptives, drugs that prolong the QT interval, drugs&#xD;
               that may cause drug interactions with investigational product, immunosuppressants,&#xD;
               vaccines or other drugs within a specific period&#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>Jing Zhang, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Huashan Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jinhua Xu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Huashan Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Huashan Hospital Affiliated to Fudan University</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200040</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>Psoriasis</mesh_term>
    </condition_browse>
    <!-- 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/NCT06033742
  org study id: HS-10374-101
  nct id: NCT06033742
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this first-in-human study is to evaluate the safety, tolerability, and
        pharmacokinetics (PK) of HS-10374 in healthy subjects.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
  time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
  measure: Number of participants with clinical laboratory abnormalities
  time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
  description: Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
  measure: Number of participants with abnormalities of vital signs
  time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
  description: Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
  measure: Number of participants with abnormalities of physical examination
  time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
  description: Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
  measure: Number of participants with abnormalities of electrocardiogram (ECG) parameters
  time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
  description: ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
  measure: Cmax
  time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
  description: Maximum plasma concentration
  measure: Tmax
  time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
  description: Time to reach Cmax
  measure: AUC
  time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
  description: Area under the plasma concentration-time curve
  measure: t½
  time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
  description: Terminal half-life
  measure: CL/F
  time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
  description: Apparent clearance
  measure: Vz/F
  time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
  description: Apparent volume of distribution
  measure: Rac
  time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
  description: Accumulation ratio
  arm group label: HS-10374
  arm group type: Experimental
  description: Single and multiple ascending doses of HS-10374 orally
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Single and multiple ascending doses of HS-10374-matched placebo orally
  intervention type: Drug
  intervention name: HS-10374 tablets
  description: Single or multiple dosing of HS-10374 orally in a fasting state
  arm group label: HS-10374
  intervention type: Drug
  intervention name: HS-10374-matched placebo tablets
  description: Single or multiple dosing of HS-10374-matched placebo orally in a fasting state
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jing Zhang, PhD
  role: Principal Investigator
  affiliation: Huashan Hospital
  last name: Jinhua Xu, MD
  role: Principal Investigator
  affiliation: Huashan Hospital
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Psoriasis