This study is only for the first in human phase 1a study designed to investigate the safety and tolerability of LIV001 in healthy participants. LIV001 will be investigated for the safety and efficacy in participants with Ulcerative Colitis (UC) in a phase 1b study.
The study will be conducted in 2 parts. Approximately 36 subjects are planned to be enrolled into the study. * In Part A (SAD), approximately 18 healthy subjects will be enrolled in 2 sequential cohorts (Cohorts SAD1 and SAD2) and randomized 2:1 to receive a single dose of investigational product (IP) (LIV001 or placebo) * In Part B (MAD), approximately 18 healthy subjects will be enrolled into 2 sequential cohorts (Cohorts MAD1 and MAD2) and randomized 2:1 to receive LIV001 or placebo for 14 days. Oversight of the study will be provided by a Safety review committee (SRC) comprising the Principal Investigator (PI), the local Medical Monitor (MM), and a representative of the Sponsor, at a minimum.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
Part A- Participants will receive single dose of 280mg capsule on day 1 under fasting conditions; Part B- Participants will receive multiple doses of 280mg capsule from day 1 to day 14 under fasting conditions;
Participants will receive matching placebo across Part A and B of the study
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Number of participants with adverse events (AEs)
Time frame: Upto 14 days from Part A; Upto 28 days for Part B
Number of participants with clinical laboratory abnormalities
Time frame: Upto 14 days from Part A; Upto 28 days for Part B
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Time frame: Upto 14 days from Part A; Upto 28 days for Part B
Number of participants with changes in stools as self assessed through Bristol stool form scale (BSFS)
Time frame: Upto 14 days from Part A; Upto 28 days for Part B
Number of participants detected tection of LIV001 in stool samples by quantitative polymerase chain reaction (qPCR)
Time frame: Upto 14 days from Part A; Upto 28 days for Part B
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