A Study of LIV001 in Healthy Subjects and Those with Mild-to-Moderate Active Ulcerative Colitis (UC)

Inclusion Criteria:

Part A (SAD) and Part B (MAD)

1. Male or female, aged 18 to 60 years (inclusive) at Screening.

2. Body mass index (BMI) 18 kg/m2 to ≤ 32 kg/m2 (inclusive) at Screening.

3. Subject is generally healthy, in the opinion of the Investigator, based onassessment of medical history, physical examination, vital signs, ECG, laboratoryparameters, and other relevant tests conducted at Screening.

4. Subject has clinical laboratory values within normal range, as specified by thetesting laboratory, at Screening and Day 1, unless deemed not clinically significantby the Investigator or delegate.

5. Nonsmoker or casual smoker who agrees to smoke ≤ 5 cigarettes per week (includese-cigarettes and other nicotine and tobacco products) during the study, includingfollow-up, and is willing to abstain from smoking/nicotine products during the CTUconfinement period(s) and for ≥ 5 days before each study visit.

6. Male and female must agree to contraceptive usage as per protocol from Screeningthrough 90 days after final dose of IP.

7. Willing and able to comply with all study-related procedures and assessments,including attending visits to the CTU.

8. Able to read and understand, and willing to sign the ICF.

9. Willing to allow storage of blood and fecal samples for future studies of geneticmake-up.

Exclusion Criteria:

Part A (SAD) and Part B (MAD)

1. Female subjects who are pregnant or lactating.

2. Abnormal ECG findings at Screening or Day -1 that are considered by the Investigatoror designee to be clinically significant.

3. Has taken prescription medication (including antibiotics) within 14 days orover-the-counter (OTC) non-prescription medication, herbal remedies, vitamins orminerals, probiotics (foods containing probiotics are permitted), and yeastsupplements (eg, Mutaflor®, Bioflor®) within 7 days prior to the first dose of IPthat may, in the opinion of the Investigator, compromise subject safety or interferewith study procedures or data validity. Subjects may be rescreened after a washoutperiod of 14 days for prescription medication or 7 days for OTC products. Use oforal contraceptives and paracetamol (1 to 2 therapeutic doses per week, ie, up to 2g per week) and/or nonsteroidal anti-inflammatory drugs for symptomatic relief ofminor symptoms is permitted.

4. Functional gastrointestinal disorders, eg, irritable bowel syndrome, functionalheartburn, functional nausea, functional dyspepsia, functional constipation, andfunctional diarrhea.

5. Substance abuse-related disorder or a history of drug, alcohol (ie, regular use of > 21 units of alcohol per week) and/or substance abuse deemed significant by theInvestigator.

6. Has taken any IP or received IP in another clinical trial within 30 days prior tothe first dose of IP or 5 half-lives, whichever is longer.

7. History of significant hypersensitivity or severe allergic or anaphylactic reactionsinvolving any drug (including ampicillin, clindamycin or imipenem), any constituentof the IP (LIV001 or its excipients), food or other precipitating agent (eg, beesting). Subjects with clinically stable mild allergic conditions such as hay feverand mild eczema may be enrolled at the discretion of the Investigator.

8. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at Screening.

9. Positive screen for drugs of abuse at Screening or Day -1, or positive screen foralcohol on Day -1.

10. Subject is, in the opinion of the Investigator, unlikely to comply with the clinicalstudy protocol or is unsuitable for any other reason.