A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

Study Overview
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Brief Summary
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Enterome small molecule drug EB8018 is a first-in-class FimH blocker to be studied in Crohn's disease patients. The proposed indication for EB8018, as an add-on therapy, will be the treatment of adult patients suffering from Crohn's disease.

Detailed Description
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This open-label, multicenter study will enroll 8 evaluable patients with active Crohn's disease and will consist of 2 parts. Part 1 will include 2 sentinel patients with a single dosing period followed by a 13-day multiple dosing period. Part 2 will include the 6 remaining patients with multiple dosing only. This Phase 1b study will investigate the PK, safety, preliminary effects of the gut microbiome, and inflammatory biomarkers of EB8018 following 13 days of consecutive BID oral dosing in patients with Crohn's disease. Part 1 of this study will demonstrate a single oral dose of EB8018 that is safe and tolerable in patients with Crohn's disease and Part 2 of this study will characterize the PK profile when administered as multiple oral doses.

Official Title
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An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients

Conditions
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Crohn Disease

Intervention / Treatment
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* Drug: EB8018 (First-in-class FimH blocker)


Participation Criteria
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Eligibility Criteria
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Selection Criteria: Male and female patients of nonchildbearing potential ≥18 years of age at screening and Day -1 Active Crohn's disease based on an elevated calprotectin at baseline.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Multicenter, open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with active Crohn's disease<br>EB8018: 3000 mg for the single dose in Part 1 (2 sentinel patients) and 1500 mg BID for multiple dose administration over 13 days in Parts 1 and 2 (2 sentinel patients and 6 remaining patients), oral. | Drug: EB8018 (First-in-class FimH blocker)<br>* Drug: EB8018 EB8018 is an orally administered, first-in-class, FimH blocker • In Part 1, a single oral dose of EB8018 3000 mg will be administered to the 2 sentinel patients in the morning on Day 1. In the multi-dose treatment period (part 1 and 2), multiple oral doses of EB8018 1500 mg will be administered to 2 + 6 patients BID (in the morning and evening) on Days 1 through 13.<br>* Other names: EB8018;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum observed plasma concentration | Day1, Day13 | 
| Tmax | Time to maximum observed plasma concentration | Day1 | 
| AUC0-24 | Area under the plasma concentration time curve from time 0 to 24 hours | Day1; Day13 | 
| T1/2 | Terminal elimination half-life | Day1; Day13 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE | Adverse events | Up to Day22 | 
| RR | Inter-Beat intervalle (sec) | Up to Day22 | 
| QRS complex | intervalle (sec) | Up to Day22 | 
| QT | duration (sec) | Up to Day22 | 
| PR | intervalle (sec) | Up to Day22 | 
| HR | Heart rate (bpm) | Up to Day22 | 
| BP | Blood pressure (mmHg) | Up to Day22 | 
| RR | Respiratory rate (breaths per minute) | Up to Day22 | 
| Temp | Temperature (C°) | Up to Day22 |