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

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.

• EB8018 (First-in-class FimH blocker) (Drug), also known as EB8018: 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.

Primary outcomes

• Cmax [Day1, Day13]: Maximum observed plasma concentration
• Tmax [Day1]: Time to maximum observed plasma concentration
• AUC0-24 [Day1; Day13]: Area under the plasma concentration time curve from time 0 to 24 hours
• T1/2 [Day1; Day13]: Terminal elimination half-life

Secondary outcomes

• AE [Up to Day22]: Adverse events
• RR [Up to Day22]: Inter-Beat intervalle (sec)
• QRS complex [Up to Day22]: intervalle (sec)
• QT [Up to Day22]: duration (sec)
• PR [Up to Day22]: intervalle (sec)
• HR [Up to Day22]: Heart rate (bpm)
• BP [Up to Day22]: Blood pressure (mmHg)
• RR [Up to Day22]: Respiratory rate (breaths per minute)
• Temp [Up to Day22]: Temperature (C°)

Other outcomes

• Gut Microbiome [Up to Day22]: Overall gene richness and relative abundance of Bacteroidetes, Enterobacteriaceae, and Firmicutes from sequencing of stool samples.
• Inflammatory Biomarkers [Up to Day22]: C-reactive protein
• Inflammatory Biomarkers [Up to Day22]: Fecal calprotectin
• 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.

Sex: All, ages: 18 Years to any

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.