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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 February 2021
• Main ID: NCT03709628
• Date of registration: 11/04/2018
• Prospective Registration: No
• Primary sponsor: Enterome
• Public title: A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients EBFIM117
• Scientific title: An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients
• Date of first enrolment: March 7, 2018
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03709628
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Austria, France, Germany, Italy

Key inclusion & 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

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

Primary Outcome(s)

Cmax [Time Frame: Day1, Day13]

AUC0-24 [Time Frame: Day1; Day13]

Tmax [Time Frame: Day1]

T1/2 [Time Frame: Day1; Day13]

Secondary Outcome(s)

QRS complex [Time Frame: Up to Day22]

AE [Time Frame: Up to Day22]

HR [Time Frame: Up to Day22]

QT [Time Frame: Up to Day22]

Temp [Time Frame: Up to Day22]

PR [Time Frame: Up to Day22]

BP [Time Frame: Up to Day22]

RR [Time Frame: Up to Day22]

Secondary ID(s)

Enterome

Source(s) of Monetary Support

Please refer to primary and secondary sponsors