Crohn Disease
Conditions
Brief 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.
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.
Interventions
DRUGEB8018 (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
Enterome
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, open-label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T1/2 | Day1; Day13 | Terminal elimination half-life |
| AUC0-24 | Day1; Day13 | Area under the plasma concentration time curve from time 0 to 24 hours |
| Tmax | Day1 | Time to maximum observed plasma concentration |
| Cmax | Day1, Day13 | Maximum observed plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QT | Up to Day22 | duration (sec) |
| HR | Up to Day22 | Heart rate (bpm) |
| BP | Up to Day22 | Blood pressure (mmHg) |
| Temp | Up to Day22 | Temperature (C°) |
| PR | Up to Day22 | intervalle (sec) |
| AE | Up to Day22 | Adverse events |
| RR | Up to Day22 | Inter-Beat intervalle (sec) |
| QRS complex | Up to Day22 | intervalle (sec) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gut Microbiome | Up to Day22 | Overall gene richness and relative abundance of Bacteroidetes, Enterobacteriaceae, and Firmicutes from sequencing of stool samples. |
| CDAI score | 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. |
| Inflammatory Biomarkers | Up to Day22 | C-reactive protein |
Countries
Austria, France, Germany, Italy
Outcome results
None listed