First-in-Human Single and Multiple Dose of EB8018

NCT ID: NCT02998190

Last Updated: 2018-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-08-31

Brief Summary

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.

Detailed 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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Single oral dose of EB8018

Single ascending doses, sequential group design

Group Type: EXPERIMENTAL

Single Ascending Doses of EB8018

Intervention Type: DRUG

Single oral dose of placebo

Single doses, matching placebo

Group Type: PLACEBO_COMPARATOR

Single Ascending Doses of placebo

Intervention Type: DRUG

Multiple oral doses of EB8018

Multiple ascending doses, daily for 14 days

Group Type: EXPERIMENTAL

Multiple Ascending Doses of EB8018

Intervention Type: DRUG

Multiple oral doses of placebo

Multiple ascending doses, daily for 14 days

Group Type: PLACEBO_COMPARATOR

Multiple Ascending Doses of placebo

Intervention Type: DRUG

Interventions

Single Ascending Doses of EB8018

Intervention Type: DRUG

Single Ascending Doses of placebo

Intervention Type: DRUG

Multiple Ascending Doses of EB8018

Intervention Type: DRUG

Multiple Ascending Doses of placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Quotient Clinical

OTHER

Sponsor Role: collaborator

Enterome

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Quotient Clinical

Ruddington, Nottingham, United Kingdom

Countries

United Kingdom

Other Identifiers

EBFIM116

Identifier Type: -

Identifier Source: org_study_id