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

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, laboratory tests, and cardiac monitoring at Screening and on Day 1.
- Participant has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.

- Participant has received live attenuated vaccination within 42 days prior to Screening or intends to have vaccinations during the course of the study.
- Participant has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to study intervention administration or participant was enrolled in an investigational drug or device study within 90 days prior to first EDP1066 dosing.

- Participant has an active infection (e.g. sepsis, pneumonia, abscess) or recurrent infection, or has had an infection requiring antibiotic treatment within 42 days prior to Investigational Medicinal Product (IMP) administration.
- Participant is diagnosed with tuberculosis (TB, as per positive skin test (Mantoux) or IFN-γ release assay), or history of TB, or latent TB, or recent contact with TB (patient);
- Participant has renal or liver impairment
- Participant has active neoplastic disease or history of neoplastic disease within 5 years of Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care).
- Impaired cardiac function or clinically significant cardiac diseases
- Participant with a positive screening result for hepatitis B surface antigen, anti-hepatitis B core, hepatitis C, or HIV.
- Participants with gastrointestinal tract disease (e.g. short bowel syndrome, diarrhoea predominant irritable bowel syndrome [IBS], celiac disease) that could interfere with the subject’s safety or pharmacodynamic effect of the monoclonal microbial.
- Serious psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent.
- Participant has a history of hypersensitivity or allergies to Lactococcus (or Lactococcus containing probiotics) including any associated excipients,
- Participant used probiotic capsules within 14 days prior to screening.
- Participant has a significant history of drug abuse or regular use of illicit drugs or a history of alcohol abuse within 1 year prior to Screening.
- Participant uses more than 10 cigarettes per day and/or is unable to refrain from cigarettes or tobacco use or other nicotine-containing products (e.g., patches) during 4 consecutive days.
- Participant has had an acute, clinically significant illness or major surgery within 30 days prior to screening.