EDP1815 – first doses in healthy volunteers and patients; ver 1
Research type
Research Study
Full title
A Phase 1a/1b participant and investigator blind Sponsor unblinded randomised placebo-controlled single and multiple ascending dose study of EDP1815 in healthy participants and participants with mild to moderate psoriasis or mild to moderate atopic dermatitis (HMR code: 18-502).
IRAS ID
250984
Contact email
Sponsor organisation
Evelo Biosciences Inc
Eudract number
2018-002807-32
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study drug, EDP1815, is an experimental new drug for treating a range of diseases, linked to problems with the immune system that cause inflammation. EDP1815 contains ‘good bacteria’ that are naturally found in some parts of the body, such as the nose, mouth and gut. Bacteria that live in our gut are sometimes able to interact with our immune system. We hope that the ‘good bacteria’ in EDP1815 will work by interacting with and changing the immune response, to reduce the symptoms of inflammatory diseases such as psoriasis and atopic dermatitis.
We’ll test single and repeated doses of EDP1815 in up to 24 healthy volunteers (Groups 1 and 2), 60 patients with psoriasis, and 48 patients with atopic dermatitis (Groups 3–7), to find out its side effects, effect on the immune system and if it improves symptoms in patients. We’ll also study how genes (pieces of DNA) and the types of bacteria in the gut affect the way the body responds to or handles EDP1815.
EDP1815 has never been given to humans before, so we’ll start with a low dose, and increase the dose as the study progresses.
We’ll give groups of 12 or 24 participants a single dose of EDP1815 or placebo, followed by repeated doses for either 14 (healthy volunteers) or up to 28 (patients) days. Healthy volunteers will take about 8 weeks to finish the study – Group 1 will stay on the ward for 5 nights and make up to 14 outpatient visits and Group 2 will make up to 20 outpatient visits. Patients with psoriasis or atopic dermatitis will make up to 12 outpatient visits, and take about 10 weeks to finish the study.
A biotechnology company Evelo Biosciences Inc is funding the study.
The study will take place at 1 centre in London.
REC name
London - Chelsea Research Ethics Committee
REC reference
18/LO/1646
Date of REC Opinion
17 Oct 2018
REC opinion
Favourable Opinion