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/NCT05996380</url>
    </required_header>
    <id_info>
      <org_study_id>SHR-3167-101</org_study_id>
      <nct_id>NCT05996380</nct_id>
    </id_info>
    <brief_title>A Phase 1 Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR-3167 Single Injection in Healthy Subjects and Patients With Type 2 Diabetes</brief_title>
    <official_title>A Phase 1 Trial to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SHR-3167 Single Injection in Healthy Subjects and Patients With Type 2 Diabetes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu HengRui 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 randomized, double-blind, placebo-controlled, single-dose escalation trial was&#xD;
        designed. There are 6 dose groups and 1 optional dose group: 0.5 mg, 2 mg, 8 mg, 25mg, 50 mg,&#xD;
        100 mg and 150 mg (optional). Eight healthy adult subjects or T2DM patients in each dose&#xD;
        group (except for 0.5 mg dose group, only 4 subjects will be enrolled) are randomly assigned&#xD;
        to subcutaneously injection of SHR-3167 or placebo according to 3:1 ratio.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 20, 2023</start_date>
    <completion_date type="Anticipated">April 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 25, 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>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety endpoints: Number of Adverse Events</measure>
      <time_frame>Start of Treatment to end of study (approximately 92 days)</time_frame>
      <description>A summary of adverse events, including Serious Adverse Events(SAEs)</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>T2DM</condition>
    <arm_group>
      <arm_group_label>SHR-3167</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>SHR-3167 Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SHR-3167</intervention_name>
      <description>SHR-3167, Single administration</description>
      <arm_group_label>SHR-3167</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>SHR-3167 Placebo</intervention_name>
      <description>SHR-3167 Placebo Single administration</description>
      <arm_group_label>SHR-3167 Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female, 18 years ≤ age ≤ 55 years (healthy subjects) or 18 years ≤ age ≤ 65&#xD;
               years (T2DM patients)&#xD;
  &#xD;
            2. 18.5 kg/m2≤ Body mass index (BMI) &lt;26.0 kg/m2 (healthy subjects) or 18.5 kg/m2≤ BMI&#xD;
               &lt;35.0kg/m2 (T2DM patients), and male weight ≥50kg and female weight ≥45kg&#xD;
  &#xD;
            3. T2DM patients: 7.0% ≤ HbA1c ≤9.5%, 7.5mmol/L≤ fasting blood glucose ≤15mmol/L&#xD;
  &#xD;
            4. Healthy subjects: 3.9 mmol/L&lt; fasting blood glucose &lt; 6.1mmol/L and HbA1c ≤6.0% at&#xD;
               screening&#xD;
  &#xD;
            5. Signed and dated informed consent indicating that the subject has been informed of all&#xD;
               pertinent aspects of the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of significant multiple and/or severe drug allergies or with a known allergy&#xD;
               to the trial product or any medicine chemically related to the trial product&#xD;
  &#xD;
            2. Presence of cancer or any clinically significant cardiac, respiratory, metabolic,&#xD;
               renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal,&#xD;
               hematological, neurological, or psychiatric diseases or disorders.&#xD;
  &#xD;
            3. History of severe cardiovascular and cerebrovascular disease, including heart failure&#xD;
               (NYHA class II to IV), myocardial infarction, unstable angina pectoris, stroke or&#xD;
               transient ischemic attack, severe arrhythmia, or coronary artery bypass grafting or&#xD;
               percutaneous coronary intervention, 6 months before screening to before randomization;&#xD;
  &#xD;
            4. T2DM patients:&#xD;
  &#xD;
               a) Severe hypoglycemia, frequent hypoglycemia, ketoacidosis, or hypertonic coma from 6&#xD;
               months before screening to before randomization; b) Known proliferative diabetic&#xD;
               retinopathy ordiabetic macular edema, or non-proliferative diabetic retinopathy&#xD;
               requiring treatment during the trial;&#xD;
  &#xD;
            5. Those who had a severe infection, severe trauma, or had undergone surgery in the 12&#xD;
               weeks prior to screening, or planned to undergo surgery during the trial&#xD;
  &#xD;
            6. Participants who participated in a clinical trial of any other drug or medical device&#xD;
               from 3 months prior to screening to before randomization or planned to participate&#xD;
               during the study period&#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>
    <overall_contact>
      <last_name>Meng Sun</last_name>
      <phone>+86 18036618718</phone>
      <email>meng.sun@hengrui.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zeming lin</last_name>
      <phone>+86 17721288239</phone>
      <email>zeming.lin.zl5@hengrui.com</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05996380
  org study id: SHR-3167-101
  nct id: NCT05996380
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, double-blind, placebo-controlled, single-dose escalation trial was
        designed. There are 6 dose groups and 1 optional dose group: 0.5 mg, 2 mg, 8 mg, 25mg, 50 mg,
        100 mg and 150 mg (optional). Eight healthy adult subjects or T2DM patients in each dose
        group (except for 0.5 mg dose group, only 4 subjects will be enrolled) are randomly assigned
        to subcutaneously injection of SHR-3167 or placebo according to 3:1 ratio.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Safety endpoints: Number of Adverse Events
  time frame: Start of Treatment to end of study (approximately 92 days)
  description: A summary of adverse events, including Serious Adverse Events(SAEs)
  arm group label: SHR-3167
  arm group type: Experimental
  arm group label: SHR-3167 Placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: SHR-3167
  description: SHR-3167, Single administration
  arm group label: SHR-3167
  intervention type: Drug
  intervention name: SHR-3167 Placebo
  description: SHR-3167 Placebo Single administration
  arm group label: SHR-3167 Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Meng Sun
  phone: +86 18036618718
  email: meng.sun@hengrui.com
  last name: Zeming lin
  phone: +86 17721288239
  email: zeming.lin.zl5@hengrui.com
  responsible party type: Sponsor
  sharing ipd: Undecided