Not Yet RecruitingPhase 1

LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)

Poland15 participantsStarted 2025-03-24

Plain-language summary

A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.)

✕. 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).

Number of subjects with adverse events (AEs)

Timeframe: Baseline through Study Completion (Week 12).

Number of subjects with clinical laboratory abnormalities

Timeframe: Baseline through Study Completion (Week 12).

Number of subjects with changes in the 12-lead electrocardiogram (ECG)

Timeframe: Baseline through Study Completion (Week 12).

NCT IDNCT06749795

SponsorLiveome Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-17

Sophie Hyun-Ja Ko, Doctor of Philosophy