Safety, PK, PD, BA and FE of EA1080 given in SAD and MAD in male HV
Research type
Research Study
Full title
A First-in-Human, Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability and Food-Effects of EA1080 in healthy Caucasian and Japanese male volunteers
IRAS ID
271490
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
EA Pharma Co., Ltd.
Eudract number
2019-001886-34
Duration of Study in the UK
1 years, 10 months, 22 days
Research summary
Inflammatory bowel disease (IBD) is a term used to describe a mixed group of diseases of the gastrointestinal tract, the main two in this group are Crohn’s disease (CD) and Ulcerative colitis (UC). IBD is characterised by the presence of inflammatory cells including cells called lymphocytes at the sites of inflammation. IBD affects more than 10 million people worldwide. CD and UC are most commonly diagnosed in young people aged between 15-30 and are chronic diseases. Severe forms of the IBD require aggressive treatment including surgery, and no cure is yet available.\n\nA common feature of IBDs is that inflammatory cells (lymphocytes) move from circulating blood into the gut, preventing this movement into the gut is a common target for drugs that aim to control symptoms. It is thought that by blocking the inflammatory cells from moving into the gut, you can reduce the symptoms or at least the severity of the symptoms.\n\nThere are already several drugs being used around the world to treat IBD patients that work in this way. EA1080 is being developed as an oral alternative to the drugs already on the market, which are injections/infusions and which use antibodies to block targets.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0454
Date of REC Opinion
19 Nov 2019
REC opinion
Favourable Opinion