Study Aim: The primary aim of this study is to assess safety and tolerability of the investigational product EDP1066 in healthy participants and patients with either mild-moderate psoriasis or mild-moderate atopic dermatitis (eczema). EDP1066 is a strain of the bacteria species Lactococcus lactis subsp. Cremoris. It is a naturally occurring organism commonly used in the production of a variety of food products for human consumption (including probiotic formulations, food processing and dairy manufacturing). You will be participating in the psoriasis participant group.
You must be aged between 18 and 60
You must have been diagnosed with mild to moderate plaque-type psoriasis for at least 6 months, affecting no more than 5% of your body (excluding scalp).
You must be willing to provide skin biopsies You must be willing to have photographs. taken of affected areas
You must have at least 2 psoriatic lesions, with at least one of these suitable for biopsy.
You must not have participated in another clinical trial using investigational drug(s) within 3 months of the first treatment period.
You must have an appropriate work permit (if you are not from the EU)
You must have a Body Mass Index of ≥ 18 kg/m2 to ≤ 35 kg/m2
If you are female you must not be pregnant, be trying to get pregnant or breastfeeding during the study. If you are male, you must not be trying to conceive with a partner.
You must be willing to provide faecal samples.
Participant has received systemic nonbiologic psoriasis therapy (methotrexate [MTX], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening.
Study Visits (All timings are approximate)
Cohort 4, 5 and 8
Visit 1 Screening – approx. 6 hours
Visits 2-10 - outpatient visits – most visits will take approximately 2 hours with some visits taking up to 6 hours. Visit 3 will take approximately 6 hours.
Visit 11 - Follow-up Visit - approx. 3 hours
The clinical team may also phone you in between visits.
For Cohort 4, 5 and 8 Compensation – £1350
Travel Expenses – Maximum £40 per visit, determined on a zone-by-zone basis