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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with active Crohn's disease | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EB8018 (First-in-class FimH blocker) | Drug | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AE | Adverse events | Up to Day22 |
| RR | Inter-Beat intervalle (sec) | Up to Day22 |
| 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 |
Selection Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Vienna | Austria | ||||
| Hôpital Claude Huriez |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Multicenter, open-label
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|
| 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 |
| 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 |
| Lille |
| France |
| Hôpital de l'Archet 2 | Nice | France |
| Universitätsklinikum Schleswig-Holstein Campus Kiel | Kiel | Germany |
| Istituto Clinico Humanitas | Rozzano | Italy |
| D007410 | Intestinal Diseases |