Trial | NCT02998190  Report issue

Title

First-in-Human Single and Multiple Dose of EB8018
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.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    eb8018 ...

  • Study Participants

    60
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.
Study Started
Nov 30
2016
Primary Completion
Apr 30
2017
Study Completion
Aug 31
2017
Last Update
Feb 13
2018

Drug Single Ascending Doses of EB8018

Drug Single Ascending Doses of placebo

Drug Multiple Ascending Doses of EB8018

Drug Multiple Ascending Doses of placebo

Single oral dose of EB8018 Experimental

Single ascending doses, sequential group design

Single oral dose of placebo Placebo Comparator

Single doses, matching placebo

Multiple oral doses of EB8018 Experimental

Multiple ascending doses, daily for 14 days

Multiple oral doses of placebo Placebo Comparator

Multiple ascending doses, daily for 14 days

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
No Results Posted