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| Name | Class |
|---|---|
| Quotient Clinical | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single oral dose of EB8018 | Experimental | Single ascending doses, sequential group design |
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| Single oral dose of placebo | Placebo Comparator | Single doses, matching placebo |
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| Multiple oral doses of EB8018 | Experimental | Multiple ascending doses, daily for 14 days |
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| Multiple oral doses of placebo | Placebo Comparator | Multiple ascending doses, daily for 14 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Ascending Doses of EB8018 | Drug |
| ||
| Single Ascending Doses of placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Between screening and 7-10 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of EB8018 in plasma | To characterize the amount of EB8018 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects | Between Day 1 predose and 48 hours after the (last) dose |
| The amount of EB8018 in urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Clinical | Ruddington | Nottingham | NG11 6JS | United Kingdom |
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| Drug |
|
| Multiple Ascending Doses of EB8018 | Drug |
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| Multiple Ascending Doses of placebo | Drug |
|
To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects |
| Between Day 1 predose and 48 hours after the (last) dose |
| The amount of EB8018 in stool | To characterize the amount of EB8018 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects | Between predose and 48 hours after the (last) dose |
| Analysis of microbiome richness | To compare the abundance of gene richness, all phyla and certain species such as E. Coli | Between predose and 48 hours after the (last) dose |