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/NCT06039254</url>
    </required_header>
    <id_info>
      <org_study_id>HRS-1780-102</org_study_id>
      <nct_id>NCT06039254</nct_id>
    </id_info>
    <brief_title>Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function</brief_title>
    <official_title>A Multicenter, Non-randomized, Open-label, Parallel-controlled Study to Evaluate the Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shandong Suncadia Medicine Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shandong Suncadia Medicine Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a multicenter, non-randomized, open-label, parallel-controlled study. The main&#xD;
        objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild&#xD;
        and moderate renal impairment versus healthy subjects, and to provide a basis for dose&#xD;
        selection of HRS-1780 in patients with chronic kidney disease.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 8, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2023</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pharmacokinetics-Cmax</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Maximum observed concentration of HRS-1780</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-AUC0-last</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pharmacokinetics-AUC0-inf</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics-Tmax</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Time to Cmax of HRS-1780</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics-t1/2</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week）</time_frame>
      <description>Terminal elimination half-life of HRS-1780</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics-CL/F</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Apparent clearance of HRS-1780</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics-Vz/F</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Apparent volume of distribution during terminal phase of HRS-1780</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics-Cumulative excretion (Ae)</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Cumulative amount of HRS-1780 excreted in urine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics-Cumulative excretion rate (Ae%)</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Cumulative percentage of HRS-1780 recovered in urine</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetics-Renal clearance (CLr)</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Clearance of HRS-1780 by kidney</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Binding rates of plasma protein (BRPP) of HRS-1780</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Binding rates of plasma protein</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>Start of Treatment to end of study (approximately 1 week)</time_frame>
      <description>Incidence and severity of adverse events</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">27</enrollment>
    <condition>Chronic Kidney Disease</condition>
    <arm_group>
      <arm_group_label>Healthy subjects group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Mild renal impairment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Moderate renal impairment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>HRS-1780</intervention_name>
      <description>Single dose in each arm</description>
      <arm_group_label>Healthy subjects group</arm_group_label>
      <arm_group_label>Mild renal impairment group</arm_group_label>
      <arm_group_label>Moderate renal impairment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Healthy subjects：&#xD;
  &#xD;
            1. Able to understand the trial procedures and possible risks, volunteers to participate&#xD;
               in the trial, willing and able to comply with all scheduled visits and study&#xD;
               procedures, and provides written informed consent.;&#xD;
  &#xD;
            2. Male and female, 18 to 70 years of age, inclusive;&#xD;
  &#xD;
            3. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;&#xD;
  &#xD;
            4. Normal glomerular filtration rate;&#xD;
  &#xD;
            5. No clinically significant abnormalities in physical examination, vital signs,&#xD;
               laboratory tests, 12-lead ECG, etc. at the investigator's discretion;&#xD;
  &#xD;
            6. Men and WOCBP must agree to take highly effective contraceptive methods detailed in&#xD;
               the protocol, have no plan to have a child from signing the consent form until at&#xD;
               least one month after IP administration, and must not undertake for sperm/egg&#xD;
               donation. Female participants should not be lactating.&#xD;
  &#xD;
          Renal impairment subjects：&#xD;
  &#xD;
            1. Able to understand the trial procedures and possible risks, volunteers to participate&#xD;
               in the trial, willing and able to comply with all scheduled visits and study&#xD;
               procedures, and provides written informed consent.;&#xD;
  &#xD;
            2. Male and female, 18 to 70 years of age, inclusive;&#xD;
  &#xD;
            3. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;&#xD;
  &#xD;
            4. Glomerular filtration rate between 30 to 89 mL/min, inclusive;&#xD;
  &#xD;
            5. Except for renal impairment and related complications, no clinically significant&#xD;
               abnormalities in physical examination, vital signs, laboratory tests, 12-lead ECG,&#xD;
               etc. at the investigator's discretion;&#xD;
  &#xD;
            6. Men and WOCBP must agree to take highly effective contraceptive methods detailed in&#xD;
               the protocol, have no plan to have a child from signing the consent form until at&#xD;
               least one month after IP administration, and must not undertake for sperm/egg&#xD;
               donation. Female participants should not be lactating.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Healthy subjects：&#xD;
  &#xD;
            1. Known history or suspected of being allergic to study drug or any component of it, or&#xD;
               significant allergic reactions to other biologic products and drugs, or severe food&#xD;
               allergies;&#xD;
  &#xD;
            2. Clinically significant abnormalities in 12-Lead ECG;&#xD;
  &#xD;
            3. Severe infections, injuries, or major surgeries as determined by the investigator&#xD;
               within 3 months prior to screening, or plans to have surgeries during the study;&#xD;
  &#xD;
            4. Receipt of medical devices or another investigational drug (including placebo) within&#xD;
               3 months or 5 half-lives, whichever is longer prior to screening, or plans to&#xD;
               participate in another clinical study during this study;&#xD;
  &#xD;
            5. Use of any prescription medicine, over-the-counter medicine, herbal remedy, or&#xD;
               nutritional supplement within 2 weeks prior to screening;&#xD;
  &#xD;
            6. Consumption of more than 14 units of alcohol per week within 6 months prior to&#xD;
               screening, or incapable to refrain from consuming alcohol during the study, or&#xD;
               positive alcohol breath test result;&#xD;
  &#xD;
            7. Consumption of more than 5 cigarettes daily (or products with an equivalent amount of&#xD;
               nicotine) within 3 months prior to screening, or use of any tobacco products 48 hours&#xD;
               prior to dosing;&#xD;
  &#xD;
            8. History of illicit or prescription drug abuse or addiction in the past 5 years, or&#xD;
               illicit or prescription drug abuse within 3 months prior to screening, or positive&#xD;
               urine drug screen;&#xD;
  &#xD;
            9. Unwilling or unable to comply with the contraceptive methods detailed in this&#xD;
               protocol;&#xD;
  &#xD;
           10. Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human&#xD;
               immunodeficiency virus, or syphilis at screening;&#xD;
  &#xD;
           11. History or evidence of clinically significant disorders and deemed not suitable to&#xD;
               participate in the study by the investigator within 6 months prior to screening;&#xD;
  &#xD;
           12. Inability to tolerate venipuncture blood collection;&#xD;
  &#xD;
           13. Any other circumstances that, in the investigator's judgment, may increase the risk to&#xD;
               the subject, or associated with the subject's participation in and completion of the&#xD;
               study.&#xD;
  &#xD;
          Renal impairment subjects：&#xD;
  &#xD;
            1. History of kidney transplant or plan to receive a kidney transplant during the trial;&#xD;
  &#xD;
            2. Known history or suspected of being allergic to study drug or any component of it, or&#xD;
               significant allergic reactions to other biologic products and drugs, or severe food&#xD;
               allergies;&#xD;
  &#xD;
            3. Clinically significant abnormalities in 12-Lead ECG;&#xD;
  &#xD;
            4. Severe infections, injuries, or major surgeries as determined by the investigator&#xD;
               within 3 months prior to screening, or plans to have surgeries during the study;&#xD;
  &#xD;
            5. Receipt of medical devices or another investigational drug (including placebo) within&#xD;
               3 months or 5 half-lives, whichever is longer prior to screening, or plans to&#xD;
               participate in another clinical study during this study;&#xD;
  &#xD;
            6. Except for treatment of renal impairment and related complications, use of other&#xD;
               prescription medicine, over-the-counter medicine, herbal remedy, or nutritional&#xD;
               supplement within 2 weeks prior to screening;&#xD;
  &#xD;
            7. Consumption of more than 14 units of alcohol per week within 6 months prior to&#xD;
               screening, or incapable to refrain from consuming alcohol during the study, or&#xD;
               positive alcohol breath test result;&#xD;
  &#xD;
            8. Consumption of more than 5 cigarettes daily (or products with an equivalent amount of&#xD;
               nicotine) within 3 months prior to screening, or use of any tobacco products 48 hours&#xD;
               prior to dosing;&#xD;
  &#xD;
            9. History of illicit or prescription drug abuse or addiction in the past 5 years, or&#xD;
               illicit or prescription drug abuse within 3 months prior to screening, or positive&#xD;
               urine drug screen;&#xD;
  &#xD;
           10. Unwilling or unable to comply with the contraceptive methods detailed in this&#xD;
               protocol;&#xD;
  &#xD;
           11. Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human&#xD;
               immunodeficiency virus, or syphilis at screening;&#xD;
  &#xD;
           12. History or evidence of clinically significant disorders and deemed not suitable to&#xD;
               participate in the study by the investigator within 6 months prior to screening;&#xD;
  &#xD;
           13. Inability to tolerate venipuncture blood collection;&#xD;
  &#xD;
           14. Any other circumstances that, in the investigator's judgment, may increase the risk to&#xD;
               the subject, or associated with the subject's participation in and completion of the&#xD;
               study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Yue Fei</last_name>
      <phone>0518-82342973</phone>
      <email>yue.fei@hengrui.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 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>Kidney Diseases</mesh_term>
      <mesh_term>Renal Insufficiency, Chronic</mesh_term>
      <mesh_term>Renal Insufficiency</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06039254
  org study id: HRS-1780-102
  nct id: NCT06039254
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a multicenter, non-randomized, open-label, parallel-controlled study. The main
        objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild
        and moderate renal impairment versus healthy subjects, and to provide a basis for dose
        selection of HRS-1780 in patients with chronic kidney disease.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pharmacokinetics-Cmax
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Maximum observed concentration of HRS-1780
  measure: Pharmacokinetics-AUC0-last
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration
  measure: Pharmacokinetics-AUC0-inf
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration
  measure: Pharmacokinetics-Tmax
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Time to Cmax of HRS-1780
  measure: Pharmacokinetics-t1/2
  time frame: Start of Treatment to end of study (approximately 1 week）
  description: Terminal elimination half-life of HRS-1780
  measure: Pharmacokinetics-CL/F
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Apparent clearance of HRS-1780
  measure: Pharmacokinetics-Vz/F
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Apparent volume of distribution during terminal phase of HRS-1780
  measure: Pharmacokinetics-Cumulative excretion (Ae)
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Cumulative amount of HRS-1780 excreted in urine
  measure: Pharmacokinetics-Cumulative excretion rate (Ae%)
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Cumulative percentage of HRS-1780 recovered in urine
  measure: Pharmacokinetics-Renal clearance (CLr)
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Clearance of HRS-1780 by kidney
  measure: Binding rates of plasma protein (BRPP) of HRS-1780
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Binding rates of plasma protein
  measure: Adverse events
  time frame: Start of Treatment to end of study (approximately 1 week)
  description: Incidence and severity of adverse events
  arm group label: Healthy subjects group
  arm group type: Experimental
  arm group label: Mild renal impairment group
  arm group type: Experimental
  arm group label: Moderate renal impairment group
  arm group type: Experimental
  intervention type: Drug
  intervention name: HRS-1780
  description: Single dose in each arm
  arm group label: Healthy subjects group
  arm group label: Mild renal impairment group
  arm group label: Moderate renal impairment group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Yue Fei
  phone: 0518-82342973
  email: yue.fei@hengrui.com
  responsible party type: Sponsor
  mesh term: Kidney Diseases
  mesh term: Renal Insufficiency, Chronic
  mesh term: Renal Insufficiency
  sharing ipd: Undecided