Ulcerative Colitis (UC)Phase 1NCT06749795
LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)
A Phase 1 study testing LIV001 in people with Ulcerative Colitis (UC), run by Liveome Inc. at 1 site in Poland.
Trial summary
A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ulcerative Colitis (UC)
- 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
- 15 participants
- Where
- 1 sitePoland
- Study dates
- 24 Mar 2025to 24 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 65 years (inclusive) at Screening.
- Established diagnosis of UC for at least 3 months prior to Screening, diagnosed by routine clinical, radiographic, endoscopic or pathologic criteria (Confirmed by colonoscopy and pathology records or, if unavailable, diagnosis confirmed by a letter from the subject's general practitioner.)
Who cannot join
- Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.
- History of a condition associated with significant immunosuppression, or chronic administration (> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to Visit 3 (subjects taking oral medications for UC, including corticosteroids or immunomodulators, are not excluded).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
Wroclaw
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled, Multi -Center, Phase 1b Study to Evaluate the Safety and Tolerability of LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis
A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis
Read the detailed description
A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of LIV001 in patients with mild to moderate UC. Patients will receive LIV001 or placebo for 8 weeks. All patients will return to the site for a follow-up visit on week 12.
- Conditions
- Ulcerative Colitis (UC)
- 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
Orally administered for 8 weeks
PlaceboDrug
Orally administered for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| LIV001 | Experimental | LIV001 will be given orally and daily from baseline until end of study Receives: Drug: LIV001 |
| Placebo | Placebo comparator | Placebo will be given orally and daily from baseline until end of study Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events (AEs)
Measured: Baseline through Study Completion (Week 12).
Number of subjects with clinical laboratory abnormalities
Measured: Baseline through Study Completion (Week 12).
Number of subjects with changes in the 12-lead electrocardiogram (ECG)
Measured: Baseline through Study Completion (Week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start24 Mar 2025 (estimated)
- Primary completion17 Jan 2026 (estimated)
- Study completion24 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative Colitis (UC)Studies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liveome Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piotr Napora, Doctor of Medicine, Principal investigator, Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749795
- Sponsor's protocol ID
- LIV001-02
- Status last verified
- Mar 2025
- First submitted
- 17 Dec 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled, Multi -Center, Phase 1b Study to Evaluate the Safety and Tolerability of LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT06749795
- Acronym / sponsor ID
- LIV001-02
- Conditions
- Ulcerative Colitis (UC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Liveome Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2025 (estimated)
- Primary completion
- 17 Jan 2026 (estimated)
- Study completion
- 24 Mar 2026 (estimated)
- First posted
- 27 Dec 2024 (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.
A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis
Detailed description
A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of LIV001 in patients with mild to moderate UC. Patients will receive LIV001 or placebo for 8 weeks. All patients will return to the site for a follow-up visit on week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIV001 | Experimental | Drug: LIV001LIV001 will be given orally and daily from baseline until end of study |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be given orally and daily from baseline until end of study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female aged 18 to 65 years (inclusive) at Screening.
- Established diagnosis of UC for at least 3 months prior to Screening, diagnosed by routine clinical, radiographic, endoscopic or pathologic criteria (Confirmed by colonoscopy and pathology records or, if unavailable, diagnosis confirmed by a letter from the subject's general practitioner.)
Key exclusion criteria (2 listed)
- Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.
- History of a condition associated with significant immunosuppression, or chronic administration (> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to Visit 3 (subjects taking oral medications for UC, including corticosteroids or immunomodulators, are not excluded).
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 |
|---|---|---|
| LIV001Orally administered for 8 weeks | Drug | LIV001 |
| PlaceboOrally administered for 8 weeks | Drug | Placebo |
Primary outcome
Number of subjects with adverse events (AEs)
Time frame: Baseline through Study Completion (Week 12).
Number of subjects with clinical laboratory abnormalities
Time frame: Baseline through Study Completion (Week 12).
Number of subjects with changes in the 12-lead electrocardiogram (ECG)
Time frame: Baseline through Study Completion (Week 12).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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.
Piotr Napora, Doctor of Medicine principal investigator
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska
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 (UC), run by Liveome Inc. at 1 site in Poland.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Mar 2025. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Hyun-Ja Ko, Doctor of Philosophy (+82-31-8065-8216, sophieko@liveome.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with adverse events (AEs) (time frame: Baseline through Study Completion (Week 12).). The study lists 3 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 24 Mar 2025.