AJM347- First in Human SAD and MAD study
Research type
Research Study
Full title
A First-in-Human, Randomised, Double Blind, Placebo Controlled, Single and Multiple Ascending Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AJM347 in Healthy Male Caucasian and Japanese Subjects in the Fasted and Fed State
IRAS ID
224577
Contact name
Jim Bush
Contact email
Sponsor organisation
EA Pharma Co Ltd
Eudract number
2017-000259-17
Duration of Study in the UK
0 years, 9 months, 29 days
Research summary
AJM347 is a drug being developed to treat Inflammatory bowel disease (IBD). It works by blocking alpha4beta7 integrin which stops symptoms of IBD. This is the first time AJM347 has been given to humans. It has been tested extensively in animals and was well tolerated (had no significant adverse effects) at doses 3 times higher than the highest dose planned for this Study. \nPart 1 will investigate single ascending doses of AJM347 or placebo (a dummy drug) in up to 96 subjects. There will be 8 cohorts of Caucasian subjects and 4 cohorts of Japanese subjects. In each Cohort 6 subjects will receive AJM347 and 2 will receive placebo. For the first Caucasian dose level two subjects (one with AJM347 and one with placebo) will be dosed 24 hours before the remaining subjects to allow time to review safety and tolerability data prior to dosing the remaining subjects in the group. Prior to each dose escalation safety data for at least 6 subjects up to 48 hours post-dose will be reviewed.\n\nIn Part 2, 40 Caucasian and Japanese subjects will participate in either 6 or 2 Treatment Periods to assess the effect of food on AJM347. \n\t\nPart 3 will investigate multiple ascending doses of AJM347 or placebo in up to 48 subjects. There will be 3 cohorts of 8 Caucasian subjects and 3 cohorts of 8 Japanese subjects. In each cohort 6 subjects will receive AJM347 and 2 subjects will receive placebo. Subjects will receive a single dose of AJM347 or placebo on Day 1 and then multiple doses twice or three times a day for 7 consecutive days between Day 3 and 9.\n
REC name
London - Brent Research Ethics Committee
REC reference
17/LO/0416
Date of REC Opinion
23 Jun 2017
REC opinion
Further Information Favourable Opinion