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First-in-Human Single and Multiple Dose of EB8018

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02998190
Recruitment Status : Completed
First Posted : December 20, 2016
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Quotient Clinical
Information provided by (Responsible Party):
Enterome

Tracking Information
First Submitted Date  ICMJE December 13, 2016
First Posted Date  ICMJE December 20, 2016
Last Update Posted Date February 13, 2018
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
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 ]
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2016)
  • The amount of EB8018 in plasma [ Time Frame: Between Day 1 predose and 48 hours after the (last) dose ]
    To characterize the amount of EB8018 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
  • The amount of EB8018 in urine [ Time Frame: Between Day 1 predose and 48 hours after the (last) dose ]
    To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
  • The amount of EB8018 in stool [ Time Frame: Between predose and 48 hours after the (last) dose ]
    To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
  • Analysis of microbiome richness [ Time Frame: Between predose and 48 hours after the (last) dose ]
    To compare the abundance of gene richness, all phyla and certain species such as E. Coli
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-Human Single and Multiple Dose of EB8018
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: Single Ascending Doses of EB8018
  • Drug: Single Ascending Doses of placebo
  • Drug: Multiple Ascending Doses of EB8018
  • Drug: Multiple Ascending Doses of placebo
Study Arms  ICMJE
  • Experimental: Single oral dose of EB8018
    Single ascending doses, sequential group design
    Intervention: Drug: Single Ascending Doses of EB8018
  • Placebo Comparator: Single oral dose of placebo
    Single doses, matching placebo
    Intervention: Drug: Single Ascending Doses of placebo
  • Experimental: Multiple oral doses of EB8018
    Multiple ascending doses, daily for 14 days
    Intervention: Drug: Multiple Ascending Doses of EB8018
  • Placebo Comparator: Multiple oral doses of placebo
    Multiple ascending doses, daily for 14 days
    Intervention: Drug: Multiple Ascending Doses of placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males
  • Age ≥ 18 to ≤ 55 years of age
  • Body mass index of 19.0 to 30.0 kg/m2
  • Normal ECG, showing no clinically relevant deviations, as judged by the investigator (QTcF ≤450 ms)

Exclusion Criteria:

  • Subjects who have received any Investigational Medicinal Product in a clinical research study within the previous 3 months.
  • History of any drug or alcohol abuse in the past 2 years
  • Regular alcohol consumption in males >21 units per week
  • Current smokers and those who have smoked within the last 12 months
  • Positive drugs of abuse test result
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever, even inactive, is not allowed.
  • Chronic infection or acute significant infection or fever within the previous 5 weeks prior to the start of IMP administration
  • Malignancy or prior malignancy, with a disease-free interval of less than 5 years after diagnosis and intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02998190
Other Study ID Numbers  ICMJE EBFIM116
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Enterome
Study Sponsor  ICMJE Enterome
Collaborators  ICMJE Quotient Clinical
Investigators  ICMJE Not Provided
PRS Account Enterome
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP