<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/NCT02998190</url>
  </required_header>
  <id_info>
    <org_study_id>EBFIM116</org_study_id>
    <nct_id>NCT02998190</nct_id>
  </id_info>
  <brief_title>First-in-Human Single and Multiple Dose of EB8018</brief_title>
  <official_title>A Randomised, Double-Blind, Placebo-Controlled Study of a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) of a FimH Antagonist, EB8018, in Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enterome</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Quotient Clinical</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Enterome</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the safety profile of single and multiple doses of&#xD;
      EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and&#xD;
      multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018&#xD;
      on the healthy male gut microbiome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Crohn's Disease is a chronic inflammatory disease of the gastrointestinal tract. Emerging&#xD;
      evidence suggests that the microbiome plays an important role in triggering an abnormal&#xD;
      mucosal immune response in patients with Crohn's Disease. Independent studies have&#xD;
      demonstrated an imbalance of the microbiome with a significant increase of E coli with&#xD;
      invasive properties, termed adherent-invasive E coli (AIEC). These AIEC bacteria attach to&#xD;
      the gut wall of susceptible patients via the fimbrial adhesion protein FimH, and subsequently&#xD;
      trigger inflammation by invading and proliferating within the gut wall. EB8018 is an oral&#xD;
      small molecule that is designed to block FimH thereby preventing the entry of AIEC into the&#xD;
      gut wall thereby disarming the bacteria without disrupting the gut microbiome.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Number of Treatment Related Adverse Event, including Abnormal Laboratory Events to evaluate the safety and tolerability profile of single ascending and multiple ascending doses of EB8018 compared with placebo in healthy subjects</measure>
    <time_frame>Between screening and 7-10 days after the last dose</time_frame>
    <description>The variables for analysis will be the difference of EB8018 compared with placebo for incidence, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The amount of EB8018 in plasma</measure>
    <time_frame>Between Day 1 predose and 48 hours after the (last) dose</time_frame>
    <description>To characterize the amount of EB8018 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The amount of EB8018 in urine</measure>
    <time_frame>Between Day 1 predose and 48 hours after the (last) dose</time_frame>
    <description>To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The amount of EB8018 in stool</measure>
    <time_frame>Between predose and 48 hours after the (last) dose</time_frame>
    <description>To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analysis of microbiome richness</measure>
    <time_frame>Between predose and 48 hours after the (last) dose</time_frame>
    <description>To compare the abundance of gene richness, all phyla and certain species such as E. Coli</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Healthy Volunteers</condition>
  <arm_group>
    <arm_group_label>Single oral dose of EB8018</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single ascending doses, sequential group design</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Single oral dose of placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single doses, matching placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple oral doses of EB8018</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multiple ascending doses, daily for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple oral doses of placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Multiple ascending doses, daily for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Single Ascending Doses of EB8018</intervention_name>
    <arm_group_label>Single oral dose of EB8018</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Single Ascending Doses of placebo</intervention_name>
    <arm_group_label>Single oral dose of placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple Ascending Doses of EB8018</intervention_name>
    <arm_group_label>Multiple oral doses of EB8018</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Multiple Ascending Doses of placebo</intervention_name>
    <arm_group_label>Multiple oral doses of placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy males&#xD;
&#xD;
          -  Age ≥ 18 to ≤ 55 years of age&#xD;
&#xD;
          -  Body mass index of 19.0 to 30.0 kg/m2&#xD;
&#xD;
          -  Normal ECG, showing no clinically relevant deviations, as judged by the investigator&#xD;
             (QTcF ≤450 ms)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have received any Investigational Medicinal Product in a clinical&#xD;
             research study within the previous 3 months.&#xD;
&#xD;
          -  History of any drug or alcohol abuse in the past 2 years&#xD;
&#xD;
          -  Regular alcohol consumption in males &gt;21 units per week&#xD;
&#xD;
          -  Current smokers and those who have smoked within the last 12 months&#xD;
&#xD;
          -  Positive drugs of abuse test result&#xD;
&#xD;
          -  Presence or history of clinically significant allergy requiring treatment, as judged&#xD;
             by the investigator. Hayfever, even inactive, is not allowed.&#xD;
&#xD;
          -  Chronic infection or acute significant infection or fever within the previous 5 weeks&#xD;
             prior to the start of IMP administration&#xD;
&#xD;
          -  Malignancy or prior malignancy, with a disease-free interval of less than 5 years&#xD;
             after diagnosis and intervention&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Quotient Clinical</name>
      <address>
        <city>Ruddington</city>
        <state>Nottingham</state>
        <zip>NG11 6JS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>February 12, 2018</last_update_submitted>
  <last_update_submitted_qc>February 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02998190
org study id: EBFIM116
nct id: NCT02998190
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the safety profile of single and multiple doses of
      EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and
      multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018
      on the healthy male gut microbiome.
Crohn's Disease is a chronic inflammatory disease of the gastrointestinal tract. Emerging
      evidence suggests that the microbiome plays an important role in triggering an abnormal
      mucosal immune response in patients with Crohn's Disease. Independent studies have
      demonstrated an imbalance of the microbiome with a significant increase of E coli with
      invasive properties, termed adherent-invasive E coli (AIEC). These AIEC bacteria attach to
      the gut wall of susceptible patients via the fimbrial adhesion protein FimH, and subsequently
      trigger inflammation by invading and proliferating within the gut wall. EB8018 is an oral
      small molecule that is designed to block FimH thereby preventing the entry of AIEC into the
      gut wall thereby disarming the bacteria without disrupting the gut microbiome.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Treatment Related Adverse Event, including Abnormal Laboratory Events to evaluate the safety and tolerability profile of single ascending and multiple ascending doses of EB8018 compared with placebo in healthy subjects
time frame: Between screening and 7-10 days after the last dose
description: The variables for analysis will be the difference of EB8018 compared with placebo for incidence, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
measure: The amount of EB8018 in plasma
time frame: Between Day 1 predose and 48 hours after the (last) dose
description: To characterize the amount of EB8018 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
measure: The amount of EB8018 in urine
time frame: Between Day 1 predose and 48 hours after the (last) dose
description: To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
measure: The amount of EB8018 in stool
time frame: Between predose and 48 hours after the (last) dose
description: To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
measure: Analysis of microbiome richness
time frame: Between predose and 48 hours after the (last) dose
description: To compare the abundance of gene richness, all phyla and certain species such as E. Coli
arm group label: Single oral dose of EB8018
arm group type: Experimental
description: Single ascending doses, sequential group design
arm group label: Single oral dose of placebo
arm group type: Placebo Comparator
description: Single doses, matching placebo
arm group label: Multiple oral doses of EB8018
arm group type: Experimental
description: Multiple ascending doses, daily for 14 days
arm group label: Multiple oral doses of placebo
arm group type: Placebo Comparator
description: Multiple ascending doses, daily for 14 days
intervention type: Drug
intervention name: Single Ascending Doses of EB8018
arm group label: Single oral dose of EB8018
intervention type: Drug
intervention name: Single Ascending Doses of placebo
arm group label: Single oral dose of placebo
intervention type: Drug
intervention name: Multiple Ascending Doses of EB8018
arm group label: Multiple oral doses of EB8018
intervention type: Drug
intervention name: Multiple Ascending Doses of placebo
arm group label: Multiple oral doses of placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No