SAD/MAD study of EB8018 in healthy male subjects (QCL117814)
Research type
Research Study
Full title
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
IRAS ID
214606
Contact name
Jean-Michel Paillarse
Contact email
Sponsor organisation
Enterome
Eudract number
2016-003368-38
Duration of Study in the UK
0 years, 4 months, 19 days
Research summary
The Sponsor is developing the study drug EB8018, for the potential treatment of adult patients with Crohn’s Disease (CD). CD is a condition which causes discomfort of the gut.
The study will try to identify the safety of single and multiple doses of EB8018 in healthy males.
The study will consist of 2 parts involving up to 44 healthy male subjects. In Part 1, there will be 3 study groups each with up to 8 subjects. Within each study group subjects will receive a single dose of either 150mg, 750mg, 1500mg EB8018 or matching placebo. A placebo is a dummy drug which does not contain any EB8018. In part 2, there will be 2 study groups each with up to 10 subjects. Within each study group subjects will receive a dose of either 750mg, 1500mg EB8018 or matching placebo as a twice a day dose. Samples of blood, urine and faeces will be taken throughout the study to look at the concentrations of EB8018 in the body.
REC name
Wales REC 1
REC reference
16/WA/0301
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion