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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05975047




Registration number
NCT05975047
Ethics application status
Date submitted
26/07/2023
Date registered
3/08/2023

Titles & IDs
Public title
A Study of LIV001 in Healthy Subjects and Those with Mild-to-Moderate Active Ulcerative Colitis (UC)
Scientific title
A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of LIV001 in Healthy Subjects and Multiple Doses of LIV001 in Subjects with Mild-to-Moderate Active Ulcerative Colitis
Secondary ID [1] 0 0
LIV001-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LIV001
Treatment: Drugs - Placebo

Experimental: LIV001 - Drug: LIV001

Dosage level:

Part A will receive single dose of either one or 10 capsules of 280 mg capsule of IP or placebo on Day 1; Part B participants will receive multiple doses of 280 mg capsule of IP or placebo from Day 1 to Day 14 after overnight fast ;

Dosage form- capsule

Route of administration- Oral

Placebo comparator: Placebo - Placebo comparator taken by participants randomized to the placebo arm across Part A, B and C of the study.


Treatment: Drugs: LIV001
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;

Treatment: Drugs: Placebo
Participants will receive matching placebo across Part A and B of the study
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with adverse events (AEs)
Timepoint [1] 0 0
Upto 14 days from Part A; Upto 28 days for Part B
Primary outcome [2] 0 0
Number of participants with clinical laboratory abnormalities
Timepoint [2] 0 0
Upto 14 days from Part A; Upto 28 days for Part B
Primary outcome [3] 0 0
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Timepoint [3] 0 0
Upto 14 days from Part A; Upto 28 days for Part B
Primary outcome [4] 0 0
Number of participants with changes in stools as self assessed through Bristol stool form scale (BSFS)
Timepoint [4] 0 0
Upto 14 days from Part A; Upto 28 days for Part B
Secondary outcome [1] 0 0
Number of participants detected tection of LIV001 in stool samples by quantitative polymerase chain reaction (qPCR)
Timepoint [1] 0 0
Upto 14 days from Part A; Upto 28 days for Part B

Eligibility
Key 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 on assessment of medical history, physical examination, vital signs, ECG, laboratory parameters, and other relevant tests conducted at Screening.
4. Subject has clinical laboratory values within normal range, as specified by the testing laboratory, at Screening and Day 1, unless deemed not clinically significant by the Investigator or delegate.
5. Nonsmoker or casual smoker who agrees to smoke = 5 cigarettes per week (includes e-cigarettes and other nicotine and tobacco products) during the study, including follow-up, and is willing to abstain from smoking/nicotine products during the CTU confinement period(s) and for = 5 days before each study visit.
6. Male and female must agree to contraceptive usage as per protocol from Screening through 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 genetic make-up.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 Investigator or designee to be clinically significant.
3. Has taken prescription medication (including antibiotics) within 14 days or over-the-counter (OTC) non-prescription medication, herbal remedies, vitamins or minerals, probiotics (foods containing probiotics are permitted), and yeast supplements (eg, Mutaflor®, Bioflor®) within 7 days prior to the first dose of IP that may, in the opinion of the Investigator, compromise subject safety or interfere with study procedures or data validity. Subjects may be rescreened after a washout period of 14 days for prescription medication or 7 days for OTC products. Use of oral contraceptives and paracetamol (1 to 2 therapeutic doses per week, ie, up to 2 g per week) and/or nonsteroidal anti-inflammatory drugs for symptomatic relief of minor symptoms is permitted.
4. Functional gastrointestinal disorders, eg, irritable bowel syndrome, functional heartburn, functional nausea, functional dyspepsia, functional constipation, and functional 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 the Investigator.
6. Has taken any IP or received IP in another clinical trial within 30 days prior to the first dose of IP or 5 half-lives, whichever is longer.
7. History of significant hypersensitivity or severe allergic or anaphylactic reactions involving any drug (including ampicillin, clindamycin or imipenem), any constituent of the IP (LIV001 or its excipients), food or other precipitating agent (eg, bee sting). Subjects with clinically stable mild allergic conditions such as hay fever and 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 for alcohol on Day -1.
10. Subject is, in the opinion of the Investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/03/2024
Sample size
Target
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Pty Ltd - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Liveome Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sophie Hyun-Ja-Ko
Address 0 0
Country 0 0
Phone 0 0
+82-31-8065-8216
Fax 0 0
Email 0 0
sophieko@liveome.co.kr
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05975047