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

NCT03709628 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Crohn Disease

Interventions

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.

Sponsors & Collaborators

  • Enterome

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-07
Primary Completion
2019-11-12
Completion
2019-12-04

Countries

  • Austria
  • France
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03709628 on ClinicalTrials.gov