A Study of a FimH Blocker, EB8018, in Crohn's Disease Patients (EBFIM117)
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|ClinicalTrials.gov Identifier: NCT03709628|
Recruitment Status : Active, not recruiting
First Posted : October 17, 2018
Last Update Posted : January 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Drug: EB8018 (First-in-class FimH blocker)||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multicenter, open-label|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter, Pharmacokinetic Study of a FimH Blocker, EB8018, in Crohn's Disease Patients|
|Actual Study Start Date :||March 7, 2018|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||October 2023|
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 Name: EB8018
- Cmax [ Time Frame: Day1, Day13 ]Maximum observed plasma concentration
- Tmax [ Time Frame: Day1 ]Time to maximum observed plasma concentration
- AUC0-24 [ Time Frame: Day1; Day13 ]Area under the plasma concentration time curve from time 0 to 24 hours
- T1/2 [ Time Frame: Day1; Day13 ]Terminal elimination half-life
- AE [ Time Frame: Up to Day22 ]Adverse events
- RR [ Time Frame: Up to Day22 ]Inter-Beat intervalle (sec)
- QRS complex [ Time Frame: Up to Day22 ]intervalle (sec)
- QT [ Time Frame: Up to Day22 ]duration (sec)
- PR [ Time Frame: Up to Day22 ]intervalle (sec)
- HR [ Time Frame: Up to Day22 ]Heart rate (bpm)
- BP [ Time Frame: Up to Day22 ]Blood pressure (mmHg)
- RR [ Time Frame: Up to Day22 ]Respiratory rate (breaths per minute)
- Temp [ Time Frame: Up to Day22 ]Temperature (C°)
- Gut Microbiome [ Time Frame: Up to Day22 ]Overall gene richness and relative abundance of Bacteroidetes, Enterobacteriaceae, and Firmicutes from sequencing of stool samples.
- Inflammatory Biomarkers [ Time Frame: Up to Day22 ]C-reactive protein
- Inflammatory Biomarkers [ Time Frame: Up to Day22 ]Fecal calprotectin
- CDAI score [ Time Frame: Up to Day22 ]CDAI calculation will be dependent on the parameters recorded in the subjects' diary and the parameters assessed at clinic visit by the investigator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709628
|Medical University Vienna|
|Hôpital Claude Huriez|
|Hôpital de l'Archet 2|
|Universitätsklinikum Schleswig-Holstein Campus Kiel|
|Istituto Clinico Humanitas|