First-in-Human Single and Multiple Dose of EB8018

Enterome

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Multiple Ascending Doses of placebo; Drug: Single Ascending Doses of placebo; Drug: Multiple Ascending Doses of EB8018; Drug: Single Ascending Doses of EB8018

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02998190

EBFIM116

Details and patient eligibility

About

The purpose of this study is to determine the safety profile of single and multiple doses of EB8018 in healthy male subjects, to determine the pharmacokinetic profile of single and multiple doses of EB8018 in healthy male subjects and to assess preliminary effects of EB8018 on the healthy male gut microbiome.

Full description

Crohn's Disease is a chronic inflammatory disease of the gastrointestinal tract. Emerging evidence suggests that the microbiome plays an important role in triggering an abnormal mucosal immune response in patients with Crohn's Disease. Independent studies have demonstrated an imbalance of the microbiome with a significant increase of E coli with invasive properties, termed adherent-invasive E coli (AIEC). These AIEC bacteria attach to the gut wall of susceptible patients via the fimbrial adhesion protein FimH, and subsequently trigger inflammation by invading and proliferating within the gut wall. EB8018 is an oral small molecule that is designed to block FimH thereby preventing the entry of AIEC into the gut wall thereby disarming the bacteria without disrupting the gut microbiome.

Enrollment: 60 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males
• Age ≥ 18 to ≤ 55 years of age
• Body mass index of 19.0 to 30.0 kg/m2
• Normal ECG, showing no clinically relevant deviations, as judged by the investigator (QTcF ≤450 ms)

Exclusion criteria

• Subjects who have received any Investigational Medicinal Product in a clinical research study within the previous 3 months.
• History of any drug or alcohol abuse in the past 2 years
• Regular alcohol consumption in males >21 units per week
• Current smokers and those who have smoked within the last 12 months
• Positive drugs of abuse test result
• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever, even inactive, is not allowed.
• Chronic infection or acute significant infection or fever within the previous 5 weeks prior to the start of IMP administration
• Malignancy or prior malignancy, with a disease-free interval of less than 5 years after diagnosis and intervention

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 4 patient groups, including a placebo group

Single oral dose of EB8018

Experimental group

Description:

Single ascending doses, sequential group design

Treatment:

Drug: Single Ascending Doses of EB8018

Single oral dose of placebo

Placebo Comparator group

Description:

Single doses, matching placebo

Treatment:

Drug: Single Ascending Doses of placebo

Multiple oral doses of EB8018

Experimental group

Description:

Multiple ascending doses, daily for 14 days

Treatment:

Drug: Multiple Ascending Doses of EB8018

Multiple oral doses of placebo

Placebo Comparator group

Description:

Multiple ascending doses, daily for 14 days

Treatment:

Drug: Multiple Ascending Doses of placebo