Ulcerative ColitisPhase 1NCT05975047
A Study of LIV001 in Healthy Subjects and Those with Mild-to-Moderate Active Ulcerative Colitis (UC)
A Phase 1 study testing LIV001 in people with Ulcerative Colitis, run by Liveome Inc. at 1 site in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- LIV001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Sep 2023to 5 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Part A (SAD) and Part B (MAD)
- Male or female, aged 18 to 60 years (inclusive) at Screening.
- Body mass index (BMI) 18 kg/m2 to ≤ 32 kg/m2 (inclusive) at Screening.
- 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.
- 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.
- 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.
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- Male and female must agree to contraceptive usage as per protocol from Screening through 90 days after final dose of IP.
- Willing and able to comply with all study-related procedures and assessments, including attending visits to the CTU.
- Able to read and understand, and willing to sign the ICF.
- Willing to allow storage of blood and fecal samples for future studies of genetic make-up.
Who cannot join
- Part A (SAD) and Part B (MAD)
- Female subjects who are pregnant or lactating.
- Abnormal ECG findings at Screening or Day -1 that are considered by the Investigator or designee to be clinically significant.
- 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.
- Functional gastrointestinal disorders, eg, irritable bowel syndrome, functional heartburn, functional nausea, functional dyspepsia, functional constipation, and functional diarrhea.
- 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.
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- 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.
- 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.
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus antibody (anti-HCV) at Screening.
- Positive screen for drugs of abuse at Screening or Day -1, or positive screen for alcohol on Day -1.
- Subject is, in the opinion of the Investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Ulcerative Colitis
- Being tested
- LIV001, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIV001Drug
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;
PlaceboDrug
Participants will receive matching placebo across Part A and B of the study
| Study group | Role | What they receive |
|---|---|---|
| LIV001 | Experimental | 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 Receives: Drug: LIV001 |
| Placebo | Placebo comparator | Placebo comparator taken by participants randomized to the placebo arm across Part A, B and C of the study. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Upto 14 days from Part A; Upto 28 days for Part B
Number of participants with clinical laboratory abnormalities
Measured: Upto 14 days from Part A; Upto 28 days for Part B
Number of participants with changes in the 12-lead electrocardiogram (ECG)
Measured: 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)
Measured: Upto 14 days from Part A; Upto 28 days for Part B
Secondary outcomes (1)
Number of participants detected tection of LIV001 in stool samples by quantitative polymerase chain reaction (qPCR)
Measured: Upto 14 days from Part A; Upto 28 days for Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start24 Sep 2023
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liveome Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975047
- Sponsor's protocol ID
- LIV001-01
- Status last verified
- Dec 2024
- First submitted
- 26 Jul 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05975047
- Acronym / sponsor ID
- LIV001-01
- Conditions
- Ulcerative Colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Liveome Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Sep 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 3 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIV001 | Experimental | Drug: LIV001Drug: 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 | Placebo comparator | Drug: PlaceboPlacebo comparator taken by participants randomized to the placebo arm across Part A, B and C of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Part A (SAD) and Part B (MAD)
- Male or female, aged 18 to 60 years (inclusive) at Screening.
- Body mass index (BMI) 18 kg/m2 to ≤ 32 kg/m2 (inclusive) at Screening.
- 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.
- 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.
Key exclusion criteria (11 listed)
- Part A (SAD) and Part B (MAD)
- Female subjects who are pregnant or lactating.
- Abnormal ECG findings at Screening or Day -1 that are considered by the Investigator or designee to be clinically significant.
- 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.
- Functional gastrointestinal disorders, eg, irritable bowel syndrome, functional heartburn, functional nausea, functional dyspepsia, functional constipation, and functional diarrhea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIV001Part 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; | Drug | LIV001 |
| PlaceboParticipants will receive matching placebo across Part A and B of the study | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LIV001 in people with Ulcerative Colitis, run by Liveome Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: Upto 14 days from Part A; Upto 28 days for Part B). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.