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

Liveome

Status and phase: Not yet enrolling; Phase 1

Conditions: Ulcerative Colitis (UC)

Treatments: Drug: LIV001; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06749795

LIV001-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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15 participants in 2 patient groups, including a placebo group

LIV001

Experimental group

Description:

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

Treatment:

Drug: LIV001

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo