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First-in-Human Single and Multiple Dose of EB8018

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Single Ascending Doses of EB8018 Drug: Single Ascending Doses of placebo Drug: Multiple Ascending Doses of EB8018 Drug: Multiple Ascending Doses of placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Actual Study Start Date : November 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : August 2017

Arm Intervention/treatment
Experimental: Single oral dose of EB8018
Single ascending doses, sequential group design
Drug: Single Ascending Doses of EB8018
Placebo Comparator: Single oral dose of placebo
Single doses, matching placebo
Drug: Single Ascending Doses of placebo
Experimental: Multiple oral doses of EB8018
Multiple ascending doses, daily for 14 days
Drug: Multiple Ascending Doses of EB8018
Placebo Comparator: Multiple oral doses of placebo
Multiple ascending doses, daily for 14 days
Drug: Multiple Ascending Doses of placebo



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02998190


Locations
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United Kingdom
Quotient Clinical
Ruddington, Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Enterome
Quotient Clinical

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Responsible Party: Enterome
ClinicalTrials.gov Identifier: NCT02998190     History of Changes
Other Study ID Numbers: EBFIM116
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No