<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/NCT03291782</url>
  </required_header>
  <id_info>
    <org_study_id>IBIO-201</org_study_id>
    <nct_id>NCT03291782</nct_id>
  </id_info>
  <brief_title>D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers</brief_title>
  <official_title>A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, and Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics; Including an Open-label Cohort to Determine the Effect of Food on the Pharmacokinetics of D-0120-NA Tablet in Healthy Volunteers in the United States</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>InventisBio Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>InventisBio Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This initial clinical study in the US will be a randomized, double-blind, placebo-controlled,&#xD;
      single-dose, dose-escalation, and sequential cohort study to evaluate the safety,&#xD;
      tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).&#xD;
&#xD;
      In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label&#xD;
      manner; once in the fasted state and once in the fed state.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 13, 2017</start_date>
  <completion_date type="Actual">August 6, 2018</completion_date>
  <primary_completion_date type="Actual">April 6, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>2 weeks</time_frame>
    <description>Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>Day-1 through 3</time_frame>
    <description>AUC: area under the plasma concentration versus time curve for D-0120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: maximum plasma drug concentration (Cmax)</measure>
    <time_frame>Day-1 through 3</time_frame>
    <description>Cmax: maximum plasma drug concentration of D-0120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: Time to reach the Cmax (Tmax)</measure>
    <time_frame>Day-1 through 3</time_frame>
    <description>Tmax: Time to reach the Cmax of D-0120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: Apparent terminal half-life (t1/2)</measure>
    <time_frame>Day-1 through 3</time_frame>
    <description>t1/2: apparent terminal half-life of D-0120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: Apparent oral clearance (CL/F)</measure>
    <time_frame>Day-1 through 3</time_frame>
    <description>CL/F: Apparent oral clearance of D-0120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic: Apparent volume of distribution (Vz/F)</measure>
    <time_frame>Day-1 through 3</time_frame>
    <description>Vz/F: Apparent volume of distribution of D-0120</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PD profile of D-0120 from plasma and urine</measure>
    <time_frame>Day-1 through 3</time_frame>
    <description>Profile in terms of Serum uric acid and creatinine; Urine uric acid and creatinine. These parameters will be combined to report fractional excretion of uric acid (FEUa %)</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Gout</condition>
  <arm_group>
    <arm_group_label>D-0120 Dose 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D-0120 Dose 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D-0120 Dose 3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D-0120 Dose 4</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>D-0120 Dose 5</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>D-0120</intervention_name>
    <description>oral, single dose</description>
    <arm_group_label>D-0120 Dose 1</arm_group_label>
    <arm_group_label>D-0120 Dose 2</arm_group_label>
    <arm_group_label>D-0120 Dose 3</arm_group_label>
    <arm_group_label>D-0120 Dose 4</arm_group_label>
    <arm_group_label>D-0120 Dose 5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must be medically documented as healthy and acceptable at physical&#xD;
             examination.&#xD;
&#xD;
          -  Subjects serum uric acid level at screening ≥ 4.5 mg/dL.&#xD;
&#xD;
          -  Subjects must have a BMI between 18.0 and 30.0 kg/m2 and a body weight of 50 kg or&#xD;
             higher&#xD;
&#xD;
          -  Subjects must have all laboratory parameters within the normal range or considered not&#xD;
             clinically significant by the principal investigator.&#xD;
&#xD;
          -  Subjects must have a normal urinalysis, eGFR, ECG or results considered not clinically&#xD;
             significant by the principal investigator.&#xD;
&#xD;
          -  Subjects are able to understand the study procedures and risks involved and must&#xD;
             provide signed informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any history or clinical manifestations of significant metabolic, hematological,&#xD;
             pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological,&#xD;
             or psychiatric disorders.&#xD;
&#xD;
          -  Any history or suspicion of kidney stones.&#xD;
&#xD;
          -  Positive for HIV, Hepatitis B, and/or Hepatitis C.&#xD;
&#xD;
          -  Subjects who have used prescription drugs, over-the-counter drugs, or herbal remedies&#xD;
             within 14 days before Day 1 of study medication dosing.&#xD;
&#xD;
          -  Undergone major surgery within 3 months prior to Day 1.&#xD;
&#xD;
          -  Women who are pregnant or breastfeeding.&#xD;
&#xD;
          -  Subjects who received any investigational test article within 5 half-lives or 30 days&#xD;
             prior to Day 1 study medication dosing.&#xD;
&#xD;
          -  Subjects who consumed Seville oranges- or grapefruit-containing foods or beverages&#xD;
             within 7 days before Day 1 and during the entire study duration.&#xD;
&#xD;
          -  Subjects with any condition that, in the judgment of the investigator, would place&#xD;
             him/her at undue risk, or potentially compromise the results or interpretation of the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hugh Coleman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Covance</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Covance Daytona Beach Clinical Research Unit</name>
      <address>
        <city>Daytona Beach</city>
        <state>Florida</state>
        <zip>32117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>December 16, 2018</last_update_submitted>
  <last_update_submitted_qc>December 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</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/NCT03291782
org study id: IBIO-201
nct id: NCT03291782
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled,
      single-dose, dose-escalation, and sequential cohort study to evaluate the safety,
      tolerability, PK and PD of D-0120-NA in fasting, healthy volunteers (HVs).

      In food effect cohort, subjects will each receive 2 doses of D-0120-NA in an open-label
      manner; once in the fasted state and once in the fed state.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of Treatment-Emergent Adverse Events
time frame: 2 weeks
description: Adverse Events and changes of Laboratory, Electrocardiogram, and Vital Signs
measure: Pharmacokinetic: area under the plasma concentration versus time curve (AUC)
time frame: Day-1 through 3
description: AUC: area under the plasma concentration versus time curve for D-0120
measure: Pharmacokinetic: maximum plasma drug concentration (Cmax)
time frame: Day-1 through 3
description: Cmax: maximum plasma drug concentration of D-0120
measure: Pharmacokinetic: Time to reach the Cmax (Tmax)
time frame: Day-1 through 3
description: Tmax: Time to reach the Cmax of D-0120
measure: Pharmacokinetic: Apparent terminal half-life (t1/2)
time frame: Day-1 through 3
description: t1/2: apparent terminal half-life of D-0120
measure: Pharmacokinetic: Apparent oral clearance (CL/F)
time frame: Day-1 through 3
description: CL/F: Apparent oral clearance of D-0120
measure: Pharmacokinetic: Apparent volume of distribution (Vz/F)
time frame: Day-1 through 3
description: Vz/F: Apparent volume of distribution of D-0120
measure: PD profile of D-0120 from plasma and urine
time frame: Day-1 through 3
description: Profile in terms of Serum uric acid and creatinine; Urine uric acid and creatinine. These parameters will be combined to report fractional excretion of uric acid (FEUa %)
arm group label: D-0120 Dose 1
arm group type: Experimental
description: D-0120 Dose 1 Patients will get D-0120 single agent or placebo of matching size during dose escalation
arm group label: D-0120 Dose 2
arm group type: Experimental
description: D-0120 Dose 2 Patients will get D-0120 single agent or placebo of matching size during dose escalation
arm group label: D-0120 Dose 3
arm group type: Experimental
description: D-0120 Dose 3 Patients will get D-0120 single agent or placebo of matching size during dose escalation
arm group label: D-0120 Dose 4
arm group type: Experimental
description: D-0120 Dose 4 Patients will get D-0120 single agent or placebo of matching size during dose escalation
arm group label: D-0120 Dose 5
arm group type: Experimental
description: D-0120 Dose 5 Patients will get D-0120 single agent once in the fasted state and once in the fed state.
intervention type: Drug
intervention name: D-0120
description: oral, single dose
arm group label: D-0120 Dose 1
arm group label: D-0120 Dose 2
arm group label: D-0120 Dose 3
arm group label: D-0120 Dose 4
arm group label: D-0120 Dose 5
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hugh Coleman, MD
role: Principal Investigator
affiliation: Covance
facility: 
country: United States
responsible party type: Sponsor