<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/NCT03007810</url>
  </required_header>
  <id_info>
    <org_study_id>HM005PS1S01</org_study_id>
    <nct_id>NCT03007810</nct_id>
  </id_info>
  <brief_title>Safety and Pharmacokinetics of Hemay005 In Healthy Male Subjects</brief_title>
  <official_title>An Ascending Single Dose Study of the Pharmacokinetics, Safety and Tolerability of Hemay005 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin Hemay Bio-Tech Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin Hemay Bio-Tech Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the&#xD;
      treatment of psoriasis. This study is the first administration of Hemay005 in humans to&#xD;
      establish the initial safety, tolerability, and pharmacokinetic profile following single&#xD;
      doses of Hemay005. A total of approximately 44 subjects will be randomized into 6&#xD;
      cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg), approximately 8 healthy subjects will be&#xD;
      enrolled (6 active and 2 placebo) at each dose cohort by sentinel method(1 active and 1&#xD;
      placebo,5 active and 1 placebo), with the exception of 10mg (4 active) cohort. This study&#xD;
      includes an 28-day Screening Period, a 1-day Treatment Period, and an End of Study Visit&#xD;
      occurring approximately 11days (±3 days) after study drug administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">June 2018</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>Number of adverse events and serious adverse events</measure>
    <time_frame>Day 1 up to Day 11±3</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cmax</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose</time_frame>
    <description>Maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tmax</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose</time_frame>
    <description>Time of maximum concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUCt</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose</time_frame>
    <description>Area under the plasma concentration-time curve from time zero extrapolated to infinity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC∞</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose</time_frame>
    <description>Area under the plasma concentration-time curve from time zero to the last quantifiable concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>t1/2</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose</time_frame>
    <description>Terminal elimination half-life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CL/F</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose</time_frame>
    <description>Apparent total plasma clearance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vz/F</measure>
    <time_frame>pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose</time_frame>
    <description>Apparent total volume of distribution</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative urinary excretion</measure>
    <time_frame>pre-dose, 0-4 hours，4-8 hours，8-12 hours，12-24 hours，24-36 hours，36-48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulative urine excretion rate</measure>
    <time_frame>pre-dose, 0-4 hours，4-8 hours，8-12 hours，12-24 hours，24-36 hours，36-48 hours post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Renal clearance</measure>
    <time_frame>pre-dose, 0-4 hours，4-8 hours，8-12 hours，12-24 hours，24-36 hours，36-48 hours post-dose</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">68</enrollment>
  <condition>Psoriasis</condition>
  <arm_group>
    <arm_group_label>Hemay005</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four subjects in cohort 1 and six subjects in each cohort (2 to 6) will receive Hemay005.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two subjects in each cohort (cohorts 2 to 6) will receive placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hemay005</intervention_name>
    <description>Subjects will be randomized into 6 cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg) orally single dose</description>
    <arm_group_label>Hemay005</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Subjects will be randomized into 5 cohorts(20mg, 40mg, 80mg, 120mg, 180mg) orally single dose</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male subjects aged 18 to 60 years;&#xD;
&#xD;
          2. Bodyweight（BW）≥ 50kg, Body mass index (BMI) in 18-28 (including upper and lower limit&#xD;
             of the range);&#xD;
&#xD;
          3. All male subjects must agree and commit to the use of a reliable contraceptive&#xD;
             regimen(including vasoligation, abstinence, using a condom) for the duration of the&#xD;
             study(from screening until 6 months after the last dose);&#xD;
&#xD;
          4. Ability to understand and be willing to sign a written informed consent before study&#xD;
             entry;&#xD;
&#xD;
          5. Subjects would have good communication with the investigator and could comply with&#xD;
             protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of clinically severe gastrointestinal, hepatic, renal, cardiovascular,&#xD;
             dermatological, immunological, respiratory, endocrine, oncological, neurological,&#xD;
             metabolic, psychiatric disease or haematological disorders;&#xD;
&#xD;
          2. Have a known history of hypersensitivity to any medicine or food, or allergy to the&#xD;
             test article or any of the excipient of the test article;&#xD;
&#xD;
          3. Have a gastrointestinal, hepatic or renal condition that may influence drug absorption&#xD;
             or metabolism;&#xD;
&#xD;
          4. A history of chronic infection (ie, tuberculosis);&#xD;
&#xD;
          5. A medical history of any clinically significant medical disease or surgery within 4&#xD;
             weeks of the screening;&#xD;
&#xD;
          6. Clinically significant laboratory abnormal results at screening or prior to the first&#xD;
             dose of study drug;&#xD;
&#xD;
          7. Clinically significant abnormal 12-lead ECG or vital signs ( systolic pressure &lt;90&#xD;
             mmHg or &gt;140 mmHg, diastolic pressure &lt;50 mmHg or &gt;90 mmHg; radial pulse rate &lt;50 bpm&#xD;
             or &gt;100 bpm);&#xD;
&#xD;
          8. Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B&#xD;
             virus surface antigen, or hepatitis C virus antibody at screening;&#xD;
&#xD;
          9. Recent history of frequent alcohol consumption, defined by average intake of greater&#xD;
             than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40%&#xD;
             alcohol content, or 150 mL wine), Participants who are unable to abstain from smoking&#xD;
             during the study or quitting smoking for less than 3 months;&#xD;
&#xD;
         10. Positive urine screen for drug and cigarettes, positive breath test for alcohol;&#xD;
&#xD;
         11. Subjects who use soft drugs (ie marijuana )within 3 months of the screening and entire&#xD;
             study duration or hard drugs (ie cocaine, phencyclidine ) within 1 year of the&#xD;
             screening and entire study duration;&#xD;
&#xD;
         12. Dietary habits or food intolerances which will interfere with the requirements for&#xD;
             participants to consume a standardised diet whilst confined to the clinical unit;&#xD;
&#xD;
         13. Participants who eat special food (Including grapefruit and/or Xanthine diet) for 14&#xD;
             days prior to dosing or any caffeine containing food or drinks, i.e. chocolate for 48&#xD;
             hours prior to dosing or drinking alcohol for 24 hours prior to dosing and not will&#xD;
             stop to intake above food and drinks;&#xD;
&#xD;
         14. Use of any drug that inhibits or induces hepatic metabolism of drugs within 30 days of&#xD;
             planned study drug administration and entire study duration (e.g. inducers:&#xD;
             barbiturates, carbamazepine, rifampicin, phenytoin, glucocorticoid and omeprazole;&#xD;
             inhibitors - SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles,&#xD;
             sedatives and hypnotics, verapamil, fluoroquinolones and antihistamines);&#xD;
&#xD;
         15. Participant who received any medicine within 14 days of the initial dose of study&#xD;
             drug;&#xD;
&#xD;
         16. Have received other clinical trials treatment within 3 months prior to study;&#xD;
&#xD;
         17. Participants who have donated of blood (&gt;400 mL) within 4 weeks of the study, or plan&#xD;
             to donate of blood during of the study and 4 weeks after the study;&#xD;
&#xD;
         18. Subjects cannot complete the study due to other reasons or by the investigator's&#xD;
             judgment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>June 17, 2018</last_update_submitted>
  <last_update_submitted_qc>June 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</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>Psoriasis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemay005</mesh_term>
  </intervention_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/NCT03007810
org study id: HM005PS1S01
nct id: NCT03007810
lead sponsor: 
has dmc: No
Hemay005 is a novel phosphodiesterase type 4(PDE4) inhibitor being developed for the
      treatment of psoriasis. This study is the first administration of Hemay005 in humans to
      establish the initial safety, tolerability, and pharmacokinetic profile following single
      doses of Hemay005. A total of approximately 44 subjects will be randomized into 6
      cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg), approximately 8 healthy subjects will be
      enrolled (6 active and 2 placebo) at each dose cohort by sentinel method(1 active and 1
      placebo,5 active and 1 placebo), with the exception of 10mg (4 active) cohort. This study
      includes an 28-day Screening Period, a 1-day Treatment Period, and an End of Study Visit
      occurring approximately 11days (±3 days) after study drug administration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of adverse events and serious adverse events
time frame: Day 1 up to Day 11±3
measure: Cmax
time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose
description: Maximum observed plasma concentration
measure: Tmax
time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose
description: Time of maximum concentration
measure: AUCt
time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose
description: Area under the plasma concentration-time curve from time zero extrapolated to infinity
measure: AUC∞
time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose
description: Area under the plasma concentration-time curve from time zero to the last quantifiable concentration
measure: t1/2
time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose
description: Terminal elimination half-life
measure: CL/F
time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose
description: Apparent total plasma clearance
measure: Vz/F
time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48 hours post-dose
description: Apparent total volume of distribution
measure: Cumulative urinary excretion
time frame: pre-dose, 0-4 hours，4-8 hours，8-12 hours，12-24 hours，24-36 hours，36-48 hours post-dose
measure: Accumulative urine excretion rate
time frame: pre-dose, 0-4 hours，4-8 hours，8-12 hours，12-24 hours，24-36 hours，36-48 hours post-dose
measure: Renal clearance
time frame: pre-dose, 0-4 hours，4-8 hours，8-12 hours，12-24 hours，24-36 hours，36-48 hours post-dose
arm group label: Hemay005
arm group type: Experimental
description: Four subjects in cohort 1 and six subjects in each cohort (2 to 6) will receive Hemay005.
arm group label: Placebo
arm group type: Placebo Comparator
description: Two subjects in each cohort (cohorts 2 to 6) will receive placebo.
intervention type: Drug
intervention name: Hemay005
description: Subjects will be randomized into 6 cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg) orally single dose
arm group label: Hemay005
intervention type: Drug
intervention name: Placebos
description: Subjects will be randomized into 5 cohorts(20mg, 40mg, 80mg, 120mg, 180mg) orally single dose
arm group label: Placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Psoriasis
mesh term: Hemay005
sharing ipd: No