LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)
Phase 1 · Testing LIV001 · 1 site · Liveome Inc.
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing LIV001 (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC).
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 15 participants are expected to take part.
- Start date: 2025-03-24 (planned).
- Main results expected around 2026-01-17 (estimate from the record).
- 1 study site listed in Poland.
Main thing being measured
- Number of subjects with adverse events (AEs) (Baseline through Study Completion (Week 12).)
In the researchers’ words
A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Liveome Inc. |
| Enrollment | 15 (estimated) |
| Start date | 2025-03-24 |
| Primary completion (est.) | 2026-01-17 |
| First posted | 2024-12-27 |
| Last updated | 2025-03-24 |
| 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 |
Interventions
- LIV001 (Drug)
Orally administered for 8 weeks - Placebo (Drug)
Orally administered for 8 weeks
Full eligibility criteria (from the record)
Inclusion Criteria: 1. Male or female aged 18 to 65 years (inclusive) at Screening. 2. 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.) Exclusion Criteria: 1. Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease. 2. 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).
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska | Wroclaw | Poland |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.