A phase 1, double-blind, randomised, placebo-controlled multiple dose study investigating the immunopharmacology of EDP1066 with multiple formulations

INTERVENTION: EDP1066 and KLH CONDITION: Auto immune diseases PRIMARY OUTCOME: • KLH challenge; o DTH after intradermal KLH re‐challenge. Response characterization by Laser Speckle Contrast Imaging (LSCI) and erythema by multispectral imaging ; o Serology: anti‐KLH IgM and IgG; o Ex vivo lymphocyte activation upon KLH re‐challenge. Response characterization by ELISPOT.; • (Changes in) regulatory T cells; • Blood chemokine and cytokine levels; SECONDARY OUTCOME: • Serious adverse event (SAE) and adverse event (AE) incidents; • Clinical safety laboratory measurements ; • Electrocardiogram (ECG) measurements ; • Vital sign measurements ; • Chemistry and hematology panels; • Physical examination ; • Bristol Stool Scale and stool questionnaire; • Persistent EDP1066 prevalence in stool samples; o Strain‐specific PCR; • Gut microbiota composition and RNA sequencing in stool samples; • Specific markers of GI integrity; o Faecal calprotectin; • Immune biomarkers, Cytokines, Immunoglobulins and Leukocyte subsets; INCLUSION CRITERIA: Participants are eligible to be included in the study only if all of the following criteria apply: ‐ Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Obtained prior to any screening procedures and in accordance with national, local, institutional guidelines. ‐ Age = 18 years to 60 years, inclusive. ‐ Participant has a body mass index of = 18 kg/m2 to = 35 kg/m2 at Screening. ‐ Effective contraception for males and females: ‐ Participant has clinical laboratory evaluations (including clinical chemistry, haematology, and complete urinalysis) within the reference range for the testing laboratory, unless the results are deemed not to be clinically significant by the investigator (1 repeat test is permitted). ‐ Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, la