<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/NCT04488900</url>
  </required_header>
  <id_info>
    <org_study_id>A104-01DL2001</org_study_id>
    <nct_id>NCT04488900</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects</brief_title>
  <official_title>A Phase 1, First-in-Human, Double-blind, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, PK and PD and Food Effect of CKD-508 After Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chong Kun Dang Pharmaceutical</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chong Kun Dang Pharmaceutical</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 study is a first-in-human, randomized, placebo-controlled, 3-part, single ascending dose&#xD;
      and multiple ascending dose study. The study is designed to assess the safety, tolerability,&#xD;
      PK, and PD of orally administered CKD-508 capsules and tablets in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 6, 2020</start_date>
  <completion_date type="Anticipated">September 16, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 16, 2022</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 Participants With Adverse Events</measure>
    <time_frame>42 days post dose</time_frame>
    <description>The relationship of each adverse event to the investigational product was assessed by the investigator.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum plasma CKD-508 concentrations after dosing</measure>
    <time_frame>42 days post dose</time_frame>
    <description>Peak plasma concentration (Cmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time of maximum plasma CKD-508 concentrations after dosing</measure>
    <time_frame>42 days post dose</time_frame>
    <description>Time of peak plasma concentration (Tmax)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes from baseline in plasma CKD-508 concentrations in time after dosing</measure>
    <time_frame>42 days post dose</time_frame>
    <description>Area under the plasma concentration versus time curve (AUC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes from baseline in LDL-c</measure>
    <time_frame>21 days post dose</time_frame>
    <description>Pharmacodynamics endpoint</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Healthy Subjects</condition>
  <arm_group>
    <arm_group_label>CKD-508 Capsule in Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of CKD-508 capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Capsule in Single Dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose of Placebo capsules</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CKD-508 Tablet in Single Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single dose of CKD-508 tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Tablet in Single Dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose of Placebo tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CKD-508 Tablet in Multiple Dose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple dose of CKD-508 tablets</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Tablet in Multiple Dose</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Multiple dose of placebo tablets</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-508 Capsule</intervention_name>
    <description>Investigational drug</description>
    <arm_group_label>CKD-508 Capsule in Single Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Capsule</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo Capsule in Single Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CKD-508 Tablet</intervention_name>
    <description>Investigational drug</description>
    <arm_group_label>CKD-508 Tablet in Multiple Dose</arm_group_label>
    <arm_group_label>CKD-508 Tablet in Single Dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo Tablet</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo Tablet in Multiple Dose</arm_group_label>
    <arm_group_label>Placebo Tablet in Single Dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject voluntarily agrees to participate in this study and signs an Independent&#xD;
             Ethics Committee (IEC)-approved informed consent prior to performing any of the&#xD;
             Screening Visit procedures.&#xD;
&#xD;
          -  Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.&#xD;
&#xD;
          -  Females of non-childbearing potential (surgically sterile [hysterectomy or&#xD;
             oophorectomy] or postmenopausal (amenorrhea for more than 12 months with&#xD;
             follicle-stimulating hormone (FSH) in postmenopausal range confirmed by an FSH test).&#xD;
&#xD;
          -  Males must be unable to procreate (defined as surgically sterile [i.e., had a&#xD;
             vasectomy ≥6 months prior to screening]) or must agree to use highly effective form of&#xD;
             birth control from screening through 90 days after study completion.&#xD;
&#xD;
          -  Non-smokers (or other nicotine use) as determined by history (no nicotine use over the&#xD;
             past 6 months).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has clinically significant history or evidence of cardiovascular, respiratory,&#xD;
             hepatic, renal, gastrointestinal, endocrine, neurological, immunological or&#xD;
             psychiatric disorder(s) as determined by the PI or designee.&#xD;
&#xD;
          -  Subject has any disorder that would interfere with the absorption, distribution,&#xD;
             metabolism or excretion of drugs.&#xD;
&#xD;
          -  Subject has any concurrent disease or condition that, in the opinion of the PI, would&#xD;
             make the subject unsuitable for participation in the clinical study.&#xD;
&#xD;
          -  Subject has history of alcohol and/or illicit drug abuse within 2 years of Screening&#xD;
             Visit.&#xD;
&#xD;
          -  Subject has positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C&#xD;
             antibody or human immunodeficiency virus (HIV) antibody.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pablo Forte Soto, M.D</last_name>
    <phone>+44 (0)1895 614355</phone>
    <email>Pablo.ForteSoto@parexel.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Northwick Park Hospital</name>
      <address>
        <city>Harrow</city>
        <state>Middlesex</state>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Krizzia Rairata</last_name>
      <phone>+44 (0)189 561 4083</phone>
      <email>Krizzia.Rairata@parexel.com</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>February 4, 2022</last_update_submitted>
  <last_update_submitted_qc>February 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04488900
org study id: A104-01DL2001
nct id: NCT04488900
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study is a first-in-human, randomized, placebo-controlled, 3-part, single ascending dose
      and multiple ascending dose study. The study is designed to assess the safety, tolerability,
      PK, and PD of orally administered CKD-508 capsules and tablets in healthy subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Number of Participants With Adverse Events
time frame: 42 days post dose
description: The relationship of each adverse event to the investigational product was assessed by the investigator.
measure: Maximum plasma CKD-508 concentrations after dosing
time frame: 42 days post dose
description: Peak plasma concentration (Cmax)
measure: Time of maximum plasma CKD-508 concentrations after dosing
time frame: 42 days post dose
description: Time of peak plasma concentration (Tmax)
measure: Changes from baseline in plasma CKD-508 concentrations in time after dosing
time frame: 42 days post dose
description: Area under the plasma concentration versus time curve (AUC)
measure: Changes from baseline in LDL-c
time frame: 21 days post dose
description: Pharmacodynamics endpoint
arm group label: CKD-508 Capsule in Single Dose
arm group type: Experimental
description: Single dose of CKD-508 capsules
arm group label: Placebo Capsule in Single Dose
arm group type: Placebo Comparator
description: Single dose of Placebo capsules
arm group label: CKD-508 Tablet in Single Dose
arm group type: Experimental
description: Single dose of CKD-508 tablets
arm group label: Placebo Tablet in Single Dose
arm group type: Placebo Comparator
description: Single dose of Placebo tablets
arm group label: CKD-508 Tablet in Multiple Dose
arm group type: Experimental
description: Multiple dose of CKD-508 tablets
arm group label: Placebo Tablet in Multiple Dose
arm group type: Placebo Comparator
description: Multiple dose of placebo tablets
intervention type: Drug
intervention name: CKD-508 Capsule
description: Investigational drug
arm group label: CKD-508 Capsule in Single Dose
intervention type: Drug
intervention name: Placebo Capsule
description: Placebo
arm group label: Placebo Capsule in Single Dose
intervention type: Drug
intervention name: CKD-508 Tablet
description: Investigational drug
arm group label: CKD-508 Tablet in Multiple Dose
arm group label: CKD-508 Tablet in Single Dose
intervention type: Drug
intervention name: Placebo Tablet
description: Placebo
arm group label: Placebo Tablet in Multiple Dose
arm group label: Placebo Tablet in Single Dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pablo Forte Soto, M.D
phone: +44 (0)1895 614355
email: Pablo.ForteSoto@parexel.com
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor