A Randomised, Double-Blind, Placebo-Controlled Study of a Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) of a FimH Antagonist, EB8018, in Healthy Volunteers.

NCT02998190 Phase 1 COMPLETED

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.

Details

Lead sponsor	Enterome
Phase	Phase 1
Status	COMPLETED
Enrolment	60
Start date	2016-11
Completion	2017-08

Conditions

• Healthy Volunteers

Interventions

• Single Ascending Doses of EB8018
• Single Ascending Doses of placebo
• Multiple Ascending Doses of EB8018
• Multiple Ascending Doses of placebo

Primary outcomes

• 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 — Between screening and 7-10 days after the last dose
  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

Countries

United Kingdom