Phase Ia/Ib Study of EDP1867 in Healthy Volunteers and Patients
Research type
Research Study
Full title
A Phase 1a/1b, first in human, participant and investigator-blind sponsor-unblinded randomized placebo-controlled multiple dose study of EDP1867 in healthy volunteers and participants with moderate atopic dermatitis and, optionally, moderate psoriasis, and/or mild asthma
IRAS ID
290450
Contact name
Pui Man Leung
Contact email
Sponsor organisation
Evelo Biosciences
Eudract number
2020-004756-14
Duration of Study in the UK
0 years, 7 months, 5 days
Research summary
The study sponsor is developing orally administered biologic medicines based on an entirely new understanding of how immunity and inflammation are controlled within the body. Results demonstrate a newly emerging, potent pathway of systemic inflammatory control centred in the small intestine. This newly defined inflammatory control pathway enables a new class of oral products to be developed which are both effective and safe.
This first-in-human (FIH) study will investigate the safety and tolerability of EDP1867 in healthy volunteers, participants with atopic dermatitis, and, optionally, in participants with psoriasis and/or asthma. The potential of EDP1867 to modify the immune system to provide benefit to these patient populations will also be assessed. Therefore, this FIH study has been designed to obtain the maximum information and understanding about the potential benefit of EDP1867 by investigating its safety and effects on the body in both healthy volunteers and in patient cohorts.
Up to 120 participants will be recruited through study sites located in the UK and will take part in one of five cohorts to assess the effects of the study drug on the body in different settings. A range of safety assessments will be undertaken throughout the study to monitor participants' health and response to the study drug. Participants with atopic dermatitis or psoriasis will also be requested to complete a range of patient questionnaires. The study is expected to last around nine months.
REC name
Wales REC 1
REC reference
20/WA/0292
Date of REC Opinion
16 Dec 2020
REC opinion
Further Information Favourable Opinion