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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-24

Study Completion Date

2026-03-24

Brief Summary

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

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Detailed Description

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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

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Ulcerative Colitis (UC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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LIV001

LIV001 will be given orally and daily from baseline until end of study

Group Type EXPERIMENTAL

LIV001

Intervention Type DRUG

Orally administered for 8 weeks

Placebo

Placebo will be given orally and daily from baseline until end of study

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Orally administered for 8 weeks

Interventions

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LIV001

Orally administered for 8 weeks

Intervention Type DRUG

Placebo

Orally administered for 8 weeks

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No