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

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease
• Intervention / Treatment: Drug: EB8018 (First-in-class FimH blocker)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria
    • Medical University Vienna
• France
  • Lille, France
    • Hopital Claude Huriez
  • Nice, France
    • Hopital de l'Archet 2
• Germany
  • Kiel, Germany
    • Universitätsklinikum Schleswig-Holstein Campus Kiel
• Italy
  • Rozzano, Italy
    • Istituto Clinico Humanitas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Patients with active Crohn's disease; 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); 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.; Other Names: EB8018

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut Microbiome	Overall gene richness and relative abundance of Bacteroidetes, Enterobacteriaceae, and Firmicutes from sequencing of stool samples.	Up to Day22
Inflammatory Biomarkers	C-reactive protein	Up to Day22
Inflammatory Biomarkers	Fecal calprotectin	Up to Day22
CDAI score	CDAI calculation will be dependent on the parameters recorded in the subjects' diary and the parameters assessed at clinic visit by the investigator.	Up to Day22

Collaborators and Investigators

• Sponsor: Enterome

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 7, 2018
• Primary Completion (ACTUAL): November 12, 2019
• Study Completion (ACTUAL): December 4, 2019

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: October 12, 2018
• First Posted (ACTUAL): October 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: Enterome

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No