A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients (EBFIM117)

Enterome

Status and phase: Completed; Phase 1

Conditions: Crohn Disease

Treatments: Drug: EB8018 (First-in-class FimH blocker)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03709628

Enterome

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Patients with active Crohn's disease

Experimental group

Description:

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.

Treatment:

Drug: EB8018 (First-in-class FimH blocker)