<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/NCT02971722</url>
  </required_header>
  <id_info>
    <org_study_id>DFBT-JY09-1</org_study_id>
    <nct_id>NCT02971722</nct_id>
  </id_info>
  <brief_title>a Study of JY09 in Chinese Healthy Subjects</brief_title>
  <official_title>Randomized,Double-blind,Placebo-controlled,Dose-escalating Phase I,Healthy Subjects Study of JY09,a Recombinant GLP-1 Receptor Agonist</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Dongfang Biotech Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Dongfang Biotech Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      JY09，is a recombinant glucagon-like peptide-1 (GLP-1) receptor agonist,constructed with&#xD;
      Exendin-4 and human Immunoglobulin G2 (IgG2) Fc fragment.Preclinical studies show that JY09&#xD;
      exhibit the expected GLP-1-mediated pharmacological effects on insulin secretion,glucose&#xD;
      covering and islet cell recovering,as well as good tolerance and safety.JY09 has been&#xD;
      approved by China food and drug administration(CFDA) to enter the clinical research&#xD;
      stage(Grant number 2016L04254).This study is designed to assess the&#xD;
      safety,tolerability,pharmacokinetics,pharmacodynamics and potential immunogenicity of JY09 in&#xD;
      healthy Chinese volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2017</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>Pharmacokinetics (PK)</measure>
    <time_frame>Baseline through day29 of period</time_frame>
    <description>Area Under the Concentration Versus Time Curve (AUC) of JY09</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>immunogenicity</measure>
    <time_frame>Baseline through day29 of period</time_frame>
    <description>A measure of the body's immune response to JY09</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.03</measure>
    <time_frame>baseline to 3 months(cohort1 and cohort 2)</time_frame>
    <description>Weight loss of subject is greater than 3 kg will be recorded as adverse events in a month</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics (PD）</measure>
    <time_frame>Baseline through day29 of period</time_frame>
    <description>Area Under the Concentration Versus Time Curve (AUC) of Glucose</description>
  </secondary_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">26</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>0.3mg JY09(cohort 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.3mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>1.5mg JY09(cohort 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1.5mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6.0mg JY09(cohort 1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo(cohort 1)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>0.7mg JY09(cohort2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.7mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3.0mg JY09(cohort2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>12.0mg JY09(cohort2)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo(cohort 2)</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JY09</intervention_name>
    <description>2mg/1ml/bottle</description>
    <arm_group_label>0.3mg JY09(cohort 1)</arm_group_label>
    <arm_group_label>0.7mg JY09(cohort2)</arm_group_label>
    <arm_group_label>1.5mg JY09(cohort 1)</arm_group_label>
    <arm_group_label>12.0mg JY09(cohort2)</arm_group_label>
    <arm_group_label>3.0mg JY09(cohort2)</arm_group_label>
    <arm_group_label>6.0mg JY09(cohort 1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>1ml/bottle</description>
    <arm_group_label>Placebo(cohort 1)</arm_group_label>
    <arm_group_label>Placebo(cohort 2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy subjects.&#xD;
&#xD;
          -  Male's mass is equal or greater than 50 kg, female's mass is equal or greater than 45&#xD;
             kg,have a body mass index (BMI) between 18 and 28 kilograms per square meter (kg/m^2),&#xD;
             inclusive.&#xD;
&#xD;
          -  The subjects sign informed consent form voluntarily.&#xD;
&#xD;
          -  The subjects agree to use instruments of contraception from the time of the first dose&#xD;
             until 6 months after the last dose of investigational drug, avoid pregnancy make&#xD;
             yourself or your mate.&#xD;
&#xD;
          -  Participants will be able to keep good communication with investigator and comply with&#xD;
             the requirements of the clinical trials&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers,quitting time less than 3 months , or can't quit smoking during the trial.&#xD;
&#xD;
          -  Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter&#xD;
             medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to&#xD;
             dosing,or being treated for a direct lower gastrointestinal or using steroids.&#xD;
&#xD;
          -  Participation in any clinical investigation within 3 months prior to dosing&#xD;
&#xD;
          -  Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing&#xD;
&#xD;
          -  Significant illness within 2 weeks prior to dosing,and investigator judge doesn't fit&#xD;
             to participate in this trial.&#xD;
&#xD;
          -  A history of clinical significance of abnormal ECG or family history of long QT&#xD;
             syndrome (grandparents, parents and siblings)&#xD;
&#xD;
          -  Have a family history of diabetes (grandparents, parents and siblings).&#xD;
&#xD;
          -  Have a history of acute or chronic bronchial spasms(including after treatment or no&#xD;
             treatment of asthma and chronic obstructive pulmonary disease )&#xD;
&#xD;
          -  Have a history of drug allergy or atopic disease allergy(asthma, urticaria, eczema,&#xD;
             dermatitis),or allergy history of trail drugs or similar drugs.&#xD;
&#xD;
          -  Have gastrointestinal diseases,such as history of liver disease, gastrointestinal&#xD;
             disease,gastrointestinal surgery (appendix removed except) or chronic pancreatitis, or&#xD;
             history of idiopathic acute pancreatitis that,in the opinion of the investigator,is&#xD;
             clinical significant.&#xD;
&#xD;
          -  Have personal or family history of medullary thyroid cancer (MTC) or a hereditary&#xD;
             disease that induce MTC .&#xD;
&#xD;
          -  Have a history of immunodeficiency disease,including human immunodeficiency virus&#xD;
             (HIV) antibody positive.&#xD;
&#xD;
          -  Have a history of needlesickness that,in the opinion of the investigator,is clinical&#xD;
             significant.&#xD;
&#xD;
          -  Have an unknown cause of infection.&#xD;
&#xD;
          -  In screening,any abnormal results of physical examination, vital&#xD;
             signs,electrocardiogram (ECG) and clinical laboratory that,in the opinion of the&#xD;
             investigator,is clinical significant.&#xD;
&#xD;
          -  Hepatitis b surface antigen or hepatitis c antibody positive, or treponema pallidum&#xD;
             antibody positive.&#xD;
&#xD;
          -  Abuse of drug or alcohol within 12 months before first dosing,or in screening found&#xD;
             evidence of abuse in laboratory tests.&#xD;
&#xD;
          -  People who are pregnant, nursing mothers, or in the near future plan to be pregnant,or&#xD;
             show pregnancy test positive before into group.&#xD;
&#xD;
          -  In screening,lying position (after 3 minutes rest) systolic blood pressure outside the&#xD;
             range 90 ~ 140 MMHG, or diastolic blood pressure outside the range 50-90 MMHG, or&#xD;
             pulse (HR) outside the range 40 ~ 100 bpm, boundary value into the group.&#xD;
&#xD;
          -  Have chang of weight &gt; 3 kg within 3 months by self-report.&#xD;
&#xD;
          -  Subjects who, in the opinion of the investigator, are in any way unsuitable to&#xD;
             participate in the study.&#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>
  <link>
    <url>http://jpet.aspetjournals.org</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Thorkildsen C, Neve S, Larsen BD, Meier E, Petersen JS. Glucagon-like peptide 1 receptor agonist ZP10A increases insulin mRNA expression and prevents diabetic progression in db/db mice. J Pharmacol Exp Ther. 2003 Nov;307(2):490-6. doi: 10.1124/jpet.103.051987. Epub 2003 Sep 15.</citation>
    <PMID>12975499</PMID>
  </reference>
  <reference>
    <citation>Bradley DP, Kulstad R, Schoeller DA. Exenatide and weight loss. Nutrition. 2010 Mar;26(3):243-9. doi: 10.1016/j.nut.2009.07.008.</citation>
    <PMID>20152707</PMID>
  </reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>December 5, 2016</last_update_submitted>
  <last_update_submitted_qc>December 5, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GLP-1 receptor agonist</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02971722
org study id: DFBT-JY09-1
nct id: NCT02971722
lead sponsor: 
has dmc: No
JY09，is a recombinant glucagon-like peptide-1 (GLP-1) receptor agonist,constructed with
      Exendin-4 and human Immunoglobulin G2 (IgG2) Fc fragment.Preclinical studies show that JY09
      exhibit the expected GLP-1-mediated pharmacological effects on insulin secretion,glucose
      covering and islet cell recovering,as well as good tolerance and safety.JY09 has been
      approved by China food and drug administration(CFDA) to enter the clinical research
      stage(Grant number 2016L04254).This study is designed to assess the
      safety,tolerability,pharmacokinetics,pharmacodynamics and potential immunogenicity of JY09 in
      healthy Chinese volunteers.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Pharmacokinetics (PK)
time frame: Baseline through day29 of period
description: Area Under the Concentration Versus Time Curve (AUC) of JY09
measure: immunogenicity
time frame: Baseline through day29 of period
description: A measure of the body's immune response to JY09
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
time frame: baseline to 3 months(cohort1 and cohort 2)
description: Weight loss of subject is greater than 3 kg will be recorded as adverse events in a month
measure: Pharmacodynamics (PD）
time frame: Baseline through day29 of period
description: Area Under the Concentration Versus Time Curve (AUC) of Glucose
arm group label: 0.3mg JY09(cohort 1)
arm group type: Experimental
description: 0.3mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
arm group label: 1.5mg JY09(cohort 1)
arm group type: Experimental
description: 1.5mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
arm group label: 6.0mg JY09(cohort 1)
arm group type: Experimental
description: 6.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
arm group label: Placebo(cohort 1)
arm group type: Placebo Comparator
description: Placebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
arm group label: 0.7mg JY09(cohort2)
arm group type: Experimental
description: 0.7mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
arm group label: 3.0mg JY09(cohort2)
arm group type: Experimental
description: 3.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
arm group label: 12.0mg JY09(cohort2)
arm group type: Experimental
description: 12.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
arm group label: Placebo(cohort 2)
arm group type: Placebo Comparator
description: Placebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
intervention type: Drug
intervention name: JY09
description: 2mg/1ml/bottle
arm group label: 0.3mg JY09(cohort 1)
arm group label: 0.7mg JY09(cohort2)
arm group label: 1.5mg JY09(cohort 1)
arm group label: 12.0mg JY09(cohort2)
arm group label: 3.0mg JY09(cohort2)
arm group label: 6.0mg JY09(cohort 1)
intervention type: Drug
intervention name: Placebo
description: 1ml/bottle
arm group label: Placebo(cohort 1)
arm group label: Placebo(cohort 2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://jpet.aspetjournals.org
description: Related Info
citation: Thorkildsen C, Neve S, Larsen BD, Meier E, Petersen JS. Glucagon-like peptide 1 receptor agonist ZP10A increases insulin mRNA expression and prevents diabetic progression in db/db mice. J Pharmacol Exp Ther. 2003 Nov;307(2):490-6. doi: 10.1124/jpet.103.051987. Epub 2003 Sep 15.
PMID: 12975499
citation: Bradley DP, Kulstad R, Schoeller DA. Exenatide and weight loss. Nutrition. 2010 Mar;26(3):243-9. doi: 10.1016/j.nut.2009.07.008.
PMID: 20152707
responsible party type: Sponsor
sharing ipd: No