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:
1. 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.
2. Age * 18 years to 60 years, inclusive.
3. Participant has a body mass index of * 18 kg/m2 to * 35 kg/m2 at Screening.
4. Contraception:
a. Male participants:
* A male participant must agree to use contraception as indicated in Section
4.5.1 during their participation in this study and for a period of 90 days
after the last dose and refrain from donating sperm during this period.
b. Female participants:
* A female participant is eligible to participate if she is not pregnant, does
not plan to become pregnant during the study, not breastfeeding, and at least 1
of the following conditions applies:
i. Not a woman of child-bearing potential (WOCBP)
OR
ii. A WOCBP who agrees to follow the contraceptive guidance during their
participation in this study as indicated in Section 4.5.1 and for at least 3
complete menstrual cycles (*90 days) after last EDP1066 dose.
5. CRP * 10 mg/L and faecal calprotectin * 150 mcg/g faeces. Exceedings of
these thresholds may be allowed by the investigator if deemed clinically
irrelevant.
6. 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).
7. 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.
8. Participant has the ability to communicate well with the Investigator in the
Dutch language and willing to comply with the study restrictions.
9. Subject needs to have sufficient space in a refrigerator to store the IMP
during the ambulant dosing phase.

1. Participant has received live attenuated vaccination within 42 days prior to
Screening or intends to have vaccinations during the course of the study.
2. 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.
3. Participant requires treatment with an anti-inflammatory drug or
prophylactic antibiotics for any reason during the study period. Paracetamol
will be permitted for use as an antipyretic and/or analgesic (maximum of 4
grams/day in any 24-hour period).
4. 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.
5. Participant is diagnosed with tuberculosis (TB, as per positive skin test
(Mantoux) or IFN-* release assay), or history of TB, or latent TB, or recent
contact with TB (patient); having travelled to countries where TB is endemic
within 56 days of planned drug administration or planning to travel to
countries where TB is endemic from the moment of drug administration until 90
days after the end of the study.
6. Participant has renal or liver impairment, defined as:
a. For women, serum creatinine level * 125 *mol/L; for men, * 135 *mol/L
b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) * 1.5 x
upper limit of normal (ULN), or
c. Alkaline phosphatase (ALP) and/or bilirubin > 1.5 x ULN
Exceedings of these thresholds may be allowed by the investigator if deemed
clinically irrelevant.
7. 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).
8. Impaired cardiac function or clinically significant cardiac diseases,
including any of the following:
a. Unstable angina or acute myocardial infarction * 90 days prior to Screening;
b. Clinically significant heart disease (e.g. symptomatic congestive heart
failure [e.g. >New York Heart Association [NYHA] Class 2]; uncontrolled
arrhythmia, or hypertension; history of labile hypertension or poor compliance
with an antihypertensive regimen.
9. Participant with a positive screening result for hepatitis B surface
antigen, anti-hepatitis B core, hepatitis C, or HIV.
10. 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.
11. Serious psychiatric or medical conditions that, in the opinion of the
investigator, could interfere with treatment, compliance, or the ability to
give consent.
12. Participant has a history of hypersensitivity or allergies to Lactococcus
(or Lactococcus containing probiotics) including any associated excipients, or
has a history of hypersensitivity or allergies to placebo capsule/powder
(magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide,
hydroxypropylmethylcellulose, or mannitol) or to the hard capsule shells
(hydroxyl propyl methyl cellulose and titanium dioxide), or has a known allergy
against Alhydrogel®.
13. Participant has a history of Schistosomiasis (infection with Schistosoma
parasite).
14. Participant has taken any over-the-counter (OTC) medication (with the
exception of paracetamol and anti-histamines) within 14 days prior to Baseline
(Day -1) or any prescription medications or nutraceuticals (e.g. supplements
including high doses of probiotics and prebiotics, as usually found in
capsules/tablets/powders) within 28 days prior to Baseline (Day -1) or
anticipates an inability to abstain from these products for the duration of the
study period. Note that probiotic and prebiotic foods e.g. yoghurts that
contain low doses are allowed.
15. Participant used probiotic capsules within 14 days prior to screening.
16. 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.
17. 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.
18. Participant has donated more than 400 mL of blood or blood products within
90 days prior to Baseline (Day -1) or plans to donate blood during the study.
19. Participant has a diastolic blood pressure *50 or *90 mm Hg, or a systolic
blood pressure *105 or *140 mm Hg at Screening or Baseline (Day -1) unless
deemed to be not clinically significant by the investigator.
20. Participant has had an acute, clinically significant illness or major
surgery within 30 days prior to screening.