First-in-Human Single and Multiple Dose of EB8018

NCT02998190 | Completed Phase 1

• 1 other identifier: EBFIM116
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Related Adverse Event, including Abnormal Laboratory Events to evaluate the safety and tolerability profile of single ascending and multiple ascending doses of EB8018 compared with placebo in healthy subjects

  The variables for analysis will be the difference of EB8018 compared with placebo for incidence, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs

  Between screening and 7-10 days after the last dose

Secondary Outcomes (4)

• The amount of EB8018 in plasma

  Between Day 1 predose and 48 hours after the (last) dose

• The amount of EB8018 in urine

  Between Day 1 predose and 48 hours after the (last) dose

• The amount of EB8018 in stool

  Between predose and 48 hours after the (last) dose

• Analysis of microbiome richness

  Between predose and 48 hours after the (last) dose

Study Arms (4)

Single oral dose of EB8018

EXPERIMENTAL

Single ascending doses, sequential group design

Drug: Single Ascending Doses of EB8018

Single oral dose of placebo

PLACEBO COMPARATOR

Single doses, matching placebo

Drug: Single Ascending Doses of placebo

Multiple oral doses of EB8018

EXPERIMENTAL

Multiple ascending doses, daily for 14 days

Drug: Multiple Ascending Doses of EB8018

Multiple oral doses of placebo

PLACEBO COMPARATOR

Multiple ascending doses, daily for 14 days

Drug: Multiple Ascending Doses of placebo

Interventions

Single Ascending Doses of EB8018 DRUG

Single oral dose of EB8018

Single Ascending Doses of placebo DRUG

Single oral dose of placebo

Multiple Ascending Doses of EB8018 DRUG

Multiple oral doses of EB8018

Multiple Ascending Doses of placebo DRUG

Multiple oral doses of placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Enterome: lead
• Quotient Clinical: collaborator

Study Sites (1)

Quotient Clinical

Ruddington, Nottingham, NG11 6JS, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 20, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: August 1, 2017
• Last Updated: February 13, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)