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A Study of LIV001 in Healthy Subjects and Those With Mild-to-Moderate Active Ulcerative Colitis (UC)
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-24
Primary completion: 2024-05-29
Study completion finish: 2024-07-30
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT05975047
Intervention or treatment
DRUG: LIV001
DRUG: Placebo
Conditions
- • Ulcerative Colitis
Find a site
Closest Location:
Nucleus Network Pty Ltd
Research sites nearby
Select from list below to view details:
Nucleus Network Pty Ltd
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: LIV001
| DRUG: LIV001
|
PLACEBO_COMPARATOR: Placebo
| DRUG: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Number of participants with adverse events (AEs) | Not Specified | Upto 14 days from Part A; Upto 28 days for Part B |
Number of participants with clinical laboratory abnormalities | Not Specified | Upto 14 days from Part A; Upto 28 days for Part B |
Number of participants with changes in the 12-lead electrocardiogram (ECG) | Not Specified | 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) | Not Specified | Upto 14 days from Part A; Upto 28 days for Part B |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Number of participants detected tection of LIV001 in stool samples by quantitative polymerase chain reaction (qPCR) | Not Specified | Upto 14 days from Part A; Upto 28 days for Part B |
Frequently Asked Questions
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