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

Phase 1

Not yet recruiting

• Conditions: Ulcerative Colitis (UC)
• Interventions: Drug: LIV001; Drug: Placebo

• Registration Number: NCT06749795
• Lead Sponsor: Liveome Inc.

Brief Summary

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 Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-23
• Study First Posted: 2024-12-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Study Start: 2025-03-24
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-01-17
• Study Completion: 2026-03-24

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIV001	LIV001	LIV001 will be given orally and daily from baseline until end of study
Placebo	Placebo	Placebo will be given orally and daily from baseline until end of study

Primary Outcome Measures

Name	Time	Method
Number of subjects with adverse events (AEs)	Baseline through Study Completion (Week 12).
Number of subjects with clinical laboratory abnormalities	Baseline through Study Completion (Week 12).
Number of subjects with changes in the 12-lead electrocardiogram (ECG)	Baseline through Study Completion (Week 12).

Trial Locations

Locations (1)

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska; 🇵🇱 Wroclaw, Poland