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First-in-Human Single and Multiple Dose of EB8018

NCT02998190 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-02-13

No results posted yet for this study

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

Interventions

DRUG

Single Ascending Doses of EB8018

DRUG

Single Ascending Doses of placebo

DRUG

Multiple Ascending Doses of EB8018

DRUG

Multiple Ascending Doses of placebo

Sponsors & Collaborators

  • Quotient Clinical

    collaborator OTHER

  • Enterome

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-04-30
Completion
2017-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02998190 on ClinicalTrials.gov