<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/NCT03769831</url>
  </required_header>
  <id_info>
    <org_study_id>SHR2285-101</org_study_id>
    <nct_id>NCT03769831</nct_id>
  </id_info>
  <brief_title>The PK/PD Study of SHR2285 Tablets in Healthy Subjects</brief_title>
  <official_title>A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR2285 Tablets in Healthy Subjects</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>
      Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of&#xD;
      cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant&#xD;
      therapies is bleeding. The primary objective of this study is to assess the safety and&#xD;
      tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide&#xD;
      information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">July 22, 2019</completion_date>
  <primary_completion_date type="Actual">July 22, 2019</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>Other</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with adverse events and serious adverse events</measure>
    <time_frame>Pre-dose to 7 days after dose administration</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC) of SHR2285</measure>
    <time_frame>Pre-dose to 2 days after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum observed serum concentration (Cmax) of SHR2285</measure>
    <time_frame>Pre-dose to 2 days after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to maximum observed serum concentration (Tmax) of SHR2285</measure>
    <time_frame>Pre-dose to 2 days after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to elimination half-life (T1/2) of SHR2285</measure>
    <time_frame>Pre-dose to 2 days after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285</measure>
    <time_frame>Pre-dose to 2 days after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285</measure>
    <time_frame>Pre-dose to 2 days after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Residence Time(MRT) of SHR2285</measure>
    <time_frame>Pre-dose to 2 days after dose administration</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of APTT, PT, INR from baseline.</measure>
    <time_frame>during Pre and Post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Thrombosis</condition>
  <arm_group>
    <arm_group_label>SHR2285</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 7 cohorts of healthy subjects will receive a single dose of oral SHR2285 tablet.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Up to 7 cohorts of healthy subjects will receive a single dose of oral placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SHR2285</intervention_name>
    <description>Ascending dose oral adminstration</description>
    <arm_group_label>SHR2285</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Ascending dose oral adminstration</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. males or females, aged 18-45&#xD;
&#xD;
          2. subjects with no cardiovascular disease, sitting blood pressure: 90mmHg ≤SBP&lt;140mmHg&#xD;
             and 50mmHg ≤DBP&lt;90mmHg;&#xD;
&#xD;
          3. body mass index (BMI) between 18 to 28, and a total body weight: male ≥50.0 kg and&#xD;
             &lt;90.0 kg; female ≥45.0 kg and &lt;90.0 kg&#xD;
&#xD;
          4. Participant in general good health. No clinically significant findings in laboratory&#xD;
             parameters or clinically significant abnormality on X-ray&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin&#xD;
             &gt; 1X ULN during screening/baseline;&#xD;
&#xD;
          2. Abnormal coagulation function;&#xD;
&#xD;
          3. A clinical history of coagulation dysfunction；subjects with adverse reaction of&#xD;
             antiplatelet drugs or anticoagulant drugs.&#xD;
&#xD;
          4. Subjects with severe trauma or surgery within 3 months prior to the screening；&#xD;
&#xD;
          5. Known blood donation within 30 days pre-dose; donating≥400 ml of blood 3 months&#xD;
             pre-dose;&#xD;
&#xD;
          6. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination,&#xD;
             hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) were&#xD;
             positive;&#xD;
&#xD;
          7. 3 months prior to screening involved in any drug or medical device clinical subjects,&#xD;
             or within 5 half-life of drugs before screening;&#xD;
&#xD;
          8. Pregnant or Serum β-hCG &gt; 5mIU/mL at baseline or women who are breastfeeding; etc.&#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>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>May 20, 2021</last_update_submitted>
  <last_update_submitted_qc>May 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 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>Thrombosis</mesh_term>
  </condition_browse>
  <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/NCT03769831
org study id: SHR2285-101
nct id: NCT03769831
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Thrombosis is a maladaptive process of vascular occlusion and remains a primary cause of
      cardiovascular morbidity and mortality, The dose-limiting issue with available anticoagulant
      therapies is bleeding. The primary objective of this study is to assess the safety and
      tolerability of SHR2285 tablets in healthy subjects. In addition, this study will provide
      information on Pharmacokinetics and Pharmacodynamics of SHR2285 tablets in healthy subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of subjects with adverse events and serious adverse events
time frame: Pre-dose to 7 days after dose administration
measure: Area under the plasma concentration versus time curve (AUC) of SHR2285
time frame: Pre-dose to 2 days after dose administration
measure: Maximum observed serum concentration (Cmax) of SHR2285
time frame: Pre-dose to 2 days after dose administration
measure: Time to maximum observed serum concentration (Tmax) of SHR2285
time frame: Pre-dose to 2 days after dose administration
measure: Time to elimination half-life (T1/2) of SHR2285
time frame: Pre-dose to 2 days after dose administration
measure: Apparent total clearance of the drug from plasma after oral administration(CL/F) of SHR2285
time frame: Pre-dose to 2 days after dose administration
measure: Apparent volume of distribution after non-intravenous administration (V/F) of SHR2285
time frame: Pre-dose to 2 days after dose administration
measure: Mean Residence Time(MRT) of SHR2285
time frame: Pre-dose to 2 days after dose administration
measure: Change of APTT, PT, INR from baseline.
time frame: during Pre and Post-dose
arm group label: SHR2285
arm group type: Experimental
description: Up to 7 cohorts of healthy subjects will receive a single dose of oral SHR2285 tablet.
arm group label: Placebo
arm group type: Experimental
description: Up to 7 cohorts of healthy subjects will receive a single dose of oral placebo.
intervention type: Drug
intervention name: SHR2285
description: Ascending dose oral adminstration
arm group label: SHR2285
intervention type: Drug
intervention name: Placebo
description: Ascending dose oral adminstration
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Thrombosis
sharing ipd: No