<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/NCT04470063</url>
  </required_header>
  <id_info>
    <org_study_id>DDO-3055-104</org_study_id>
    <nct_id>NCT04470063</nct_id>
  </id_info>
  <brief_title>Multi-dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases.</brief_title>
  <official_title>A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multi-dose DDO-3055 Tablets in Patients With Anemia of Non-dialysis Chronic Kidney Diseases-Randomized, Double-blind, Dose Escalation, Placebo Controlled Phase I Clinical Trial.</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>
    <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 study is being conducted to evaluate the safety, tolerability, pharmacokinetics and&#xD;
      pharmacodynamics of multi-dose DDO-3055 tablets in patients with anemia of non-dialysis&#xD;
      chronic kidney diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">November 17, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>The incidence and severity of adverse events to assess safety and tolerability.</measure>
    <time_frame>up to 37 days</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Anemia Associated Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DDO-3055 tablets</intervention_name>
    <description>Multi-dose for DDO-3055 tablets</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
    <arm_group_label>group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Multi-dose for Placebo</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
    <arm_group_label>group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with CKD anemia aged 18-70 years who were not on dialysis and were not&#xD;
             expected to undergo dialysis during the study period, regardless of gender;&#xD;
&#xD;
          -  Male weight≥50kg, female weight≥45kg, and 19kg/m2≤BMI&lt;28kg/m2;&#xD;
&#xD;
          -  Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic constitution, suspected to be allergic to the study drug or any component in&#xD;
             the study drug;&#xD;
&#xD;
          -  Patients with acute coronary syndrome, stroke, thromboembolism (such as deep vein&#xD;
             thrombosis or pulmonary embolism) or a history of seizures within 6 months before&#xD;
             screening;&#xD;
&#xD;
          -  Patients with uncontroll ed hypertension;&#xD;
&#xD;
          -  New York Heart Association grade III or IV congestive heart failure at the time of&#xD;
             screening;&#xD;
&#xD;
          -  ALT,AST or total bilirubin exceeds 1.5 times the upper limit of normal value (ULN)&#xD;
             during the screening period;&#xD;
&#xD;
          -  Suffer from anemia other than CKD.&#xD;
&#xD;
          -  Patients with a history of chronic liver disease;&#xD;
&#xD;
          -  Patients with active bleeding or known coagulopathy;&#xD;
&#xD;
          -  Patients who have any previous organ transplant or plan to perform organ transplant;&#xD;
&#xD;
          -  Intravenous iron supplementation within 1 month before screening;&#xD;
&#xD;
          -  Used erythropoiesis stimulator (ESAs), hypoxia-inducible factor-prolyl hydroxylase&#xD;
             inhibitor (HIF-PHI), androgen, blood transfusion therapy within 3 months before&#xD;
             screening;&#xD;
&#xD;
          -  Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody,&#xD;
             and human immunodeficiency virus (HIV) antibody were positive;&#xD;
&#xD;
          -  Patients with blood loss ≥400mL within 3 months before screening;&#xD;
&#xD;
          -  Subjects who have taken other clinical trial drugs or are expected to have a legacy&#xD;
             effect of the trial treatment;&#xD;
&#xD;
          -  Participants who are unwilling to take contraception or male subjects who cannot&#xD;
             guarantee not to donate sperm during the trial and within 30 days after the last dose;&#xD;
             female subjects with fertility who did not use contraception for at least 14 days&#xD;
             before dosing;or male and female subjects who did not agree to use physical&#xD;
             contraception during the trial;&#xD;
&#xD;
          -  Patients who had a positive blood pregnancy test and were breastfeeding at the time of&#xD;
             screening;&#xD;
&#xD;
          -  According to the study physician's judgment, there may be any other anemia factors&#xD;
             that may exist, any possibility to increase the risk of the study, affect the&#xD;
             subject's compliance with the protocol, or affect the physical or psychological&#xD;
             disease or condition of the subject to complete the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beijing Friendship Hospital,Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Affiliated Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sun Yat Sen memorial hospital Sun Yat Sen university</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital，Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen Second People's Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cangzhou People's Hospital</name>
      <address>
        <city>Cangzhou</city>
        <state>Henbei</state>
        <zip>075000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yichang Central People's Hospital</name>
      <address>
        <city>Yichang</city>
        <state>Hubei</state>
        <zip>443000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zhongda Hospital Southeast Universtiy</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shandong Qianfo Mountain hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Qingdao University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <zip>266555</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610044</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>October 24, 2021</last_update_submitted>
  <last_update_submitted_qc>October 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</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>Anemia</mesh_term>
  </condition_browse>
  <!-- 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/NCT04470063
org study id: DDO-3055-104
nct id: NCT04470063
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of multi-dose DDO-3055 tablets in patients with anemia of non-dialysis
      chronic kidney diseases.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: The incidence and severity of adverse events to assess safety and tolerability.
time frame: up to 37 days
arm group label: group A
arm group type: Experimental
arm group label: group B
arm group type: Experimental
arm group label: group C
arm group type: Experimental
intervention type: Drug
intervention name: DDO-3055 tablets
description: Multi-dose for DDO-3055 tablets
arm group label: group A
arm group label: group B
arm group label: group C
intervention type: Drug
intervention name: Placebo
description: Multi-dose for Placebo
arm group label: group A
arm group label: group B
arm group label: group C
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Anemia