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/NCT06041165</url>
    </required_header>
    <id_info>
      <org_study_id>JS401-001</org_study_id>
      <nct_id>NCT06041165</nct_id>
    </id_info>
    <brief_title>A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of JS401</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Kinetic Effects in Healthy Volunteers With Normal or Mildly Elevated Triglycerides</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shanghai Junshi Bioscience Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shanghai Junshi Bioscience 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>
        The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and&#xD;
        pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated&#xD;
        triglycerides.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 31, 2023</start_date>
    <completion_date type="Anticipated">September 21, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 29, 2024</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>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Number of Participants with Adverse Events (AEs)</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Number of Participants with Adverse Events (AEs)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Peak Plasma Concentration (Cmax)</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>Peak Plasma Concentration of JS401</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to Maximum Plasma Concentration (Tmax)</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>Time to Maximum Plasma Concentration of JS401</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Terminal Elimination Half-Life (t1/2)</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>Terminal Elimination Half-Life (t1/2) of JS401</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Area Under the Plasma Concentration Versus Time Curve (AUC)</measure>
      <time_frame>Up to 48 hours post-dose</time_frame>
      <description>Area Under the Plasma Concentration Versus Time Curve of JS401</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Angiopoietin-like 3 (ANGPTL3)</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Triglycerides</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Reduction in Fasting Serum LDL-C from Pre-Dose Baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>immunogenic characteristics ADA of JS401</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>The number and percentage of subjects who were positive for anti-JS401 anti-drug antibody (ADA) after administration of JS401 injection were counted, and the titer of ADA-positive samples was analyzed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Low-density lipoprotein cholesterol (LDL-C)</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Reduction in Fasting Serum LDL-C from Pre-Dose Baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Non-high-density lipoprotein cholesterol (non-HDL-C)</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Reduction in Fasting Serum non-HDL-C from Pre-Dose Baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Very low-density lipoprotein cholesterol (VLDL-C)</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>High-density lipoprotein cholesterol (HDL-C)</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Reduction in Fasting SerumHDL-C from Pre-Dose Baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lipoprotein (a) (Lp(a))</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Reduction in Fasting Lp(a) from Pre-Dose Baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apolipoprotein B (ApoB)</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Reduction in Fasting ApoB from Pre-Dose Baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Apolipoprotein A1 (ApoA1)</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Reduction in Fasting ApoA1 from Pre-Dose Baseline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Q-T interval</measure>
      <time_frame>Up to 112 days post-dose</time_frame>
      <description>Change in QTc from baseline</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Hyperlipidemia</condition>
    <arm_group>
      <arm_group_label>Experimental: JS401 injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>JS401</intervention_name>
      <description>Single dose of JS401 by subcutaneous (sc) injections</description>
      <arm_group_label>Experimental: JS401 injection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Calculated volume to match active treatment</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Healthy male or female subjects aged 18~60 (inclusive) at the time of signing the ICF,&#xD;
               with no less than 1/3 of either gender;&#xD;
  &#xD;
            2. Fasting TG≥1.1mmol/L (100 mg/dL) and ≤ 5.0mmol/L (450mg/dL) at screening; (3) Fasting&#xD;
               LDL-C at screening&gt; 1.8 mmol/L (70 mg/dL).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Have a medical history or clinical evidence that the subject has obvious concomitant&#xD;
               diseases (including but not limited to: cardiovascular, respiratory, digestive,&#xD;
               urinary, neurological, blood, immunological, endocrine and metabolic, infection,&#xD;
               etc.), or any clinically significant abnormalities found in physical examination,&#xD;
               laboratory examination, and ECG examination, which are judged by the investigator to&#xD;
               not meet the standards of clinical health or are not suitable for participating in&#xD;
               clinical trials;&#xD;
  &#xD;
            2. Acute or chronic infection requiring hospitalization or undergoing systemic parenteral&#xD;
               therapy (antiviral/bacterial/fungal/parasitic, etc.) within 60 days prior to&#xD;
               randomization;&#xD;
  &#xD;
            3. Positive for syphilis antibodies, or positive for human immunodeficiency virus (HIV)&#xD;
               antibodies, or positive for hepatitis C virus (HCV) antibodies, or positive for&#xD;
               hepatitis B virus surface antigen (HBsAg) at screening;&#xD;
  &#xD;
            4. History of substance abuse within 12 months prior to screening, or positive urine drug&#xD;
               screening at screening;&#xD;
  &#xD;
            5. History of alcohol dependence within 6 months prior to screening, or positive breath&#xD;
               test for alcohol at screening&#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_contact>
      <last_name>Fugui Wang</last_name>
      <phone>8613511074153</phone>
      <email>fugui_wang@junshipharma.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100191</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Fangfang Wang, PhD</last_name>
        <phone>8615611963416</phone>
        <email>doctorfancy@126.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 1, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 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>Hyperlipidemias</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/NCT06041165
  org study id: JS401-001
  nct id: NCT06041165
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to evaluate the safety, tolerability, pharmacokinetcs and
        pharmacodynamics of single-dose of JS401 in healthy volunteers with normal or mildly elevated
        triglycerides.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Number of Participants with Adverse Events (AEs)
  time frame: Up to 112 days post-dose
  description: Number of Participants with Adverse Events (AEs)
  measure: Peak Plasma Concentration (Cmax)
  time frame: Up to 48 hours post-dose
  description: Peak Plasma Concentration of JS401
  measure: Time to Maximum Plasma Concentration (Tmax)
  time frame: Up to 48 hours post-dose
  description: Time to Maximum Plasma Concentration of JS401
  measure: Terminal Elimination Half-Life (t1/2)
  time frame: Up to 48 hours post-dose
  description: Terminal Elimination Half-Life (t1/2) of JS401
  measure: Area Under the Plasma Concentration Versus Time Curve (AUC)
  time frame: Up to 48 hours post-dose
  description: Area Under the Plasma Concentration Versus Time Curve of JS401
  measure: Angiopoietin-like 3 (ANGPTL3)
  time frame: Up to 112 days post-dose
  description: Reduction in Fasting Serum ANGPTL3 from Pre-Dose Baseline
  measure: Triglycerides
  time frame: Up to 112 days post-dose
  description: Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
  measure: immunogenic characteristics ADA of JS401
  time frame: Up to 112 days post-dose
  description: The number and percentage of subjects who were positive for anti-JS401 anti-drug antibody (ADA) after administration of JS401 injection were counted, and the titer of ADA-positive samples was analyzed.
  measure: Low-density lipoprotein cholesterol (LDL-C)
  time frame: Up to 112 days post-dose
  description: Reduction in Fasting Serum LDL-C from Pre-Dose Baseline
  measure: Non-high-density lipoprotein cholesterol (non-HDL-C)
  time frame: Up to 112 days post-dose
  description: Reduction in Fasting Serum non-HDL-C from Pre-Dose Baseline
  measure: Very low-density lipoprotein cholesterol (VLDL-C)
  time frame: Up to 112 days post-dose
  description: Reduction in Fasting Serum VLDL-C from Pre-Dose Baseline
  measure: High-density lipoprotein cholesterol (HDL-C)
  time frame: Up to 112 days post-dose
  description: Reduction in Fasting SerumHDL-C from Pre-Dose Baseline
  measure: Lipoprotein (a) (Lp(a))
  time frame: Up to 112 days post-dose
  description: Reduction in Fasting Lp(a) from Pre-Dose Baseline
  measure: Apolipoprotein B (ApoB)
  time frame: Up to 112 days post-dose
  description: Reduction in Fasting ApoB from Pre-Dose Baseline
  measure: Apolipoprotein A1 (ApoA1)
  time frame: Up to 112 days post-dose
  description: Reduction in Fasting ApoA1 from Pre-Dose Baseline
  measure: Q-T interval
  time frame: Up to 112 days post-dose
  description: Change in QTc from baseline
  arm group label: Experimental: JS401 injection
  arm group type: Experimental
  arm group label: Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: JS401
  description: Single dose of JS401 by subcutaneous (sc) injections
  arm group label: Experimental: JS401 injection
  intervention type: Drug
  intervention name: Placebo
  description: Calculated volume to match active treatment
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Fugui Wang
  phone: 8613511074153
  email: fugui_wang@junshipharma.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Hyperlipidemias
  sharing ipd: No