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

NCT06749795 | Not Yet Recruiting Phase 1

• 1 other identifier: LIV001-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (3)

• 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).

Study Arms (2)

LIV001

EXPERIMENTAL

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

Drug: LIV001

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

LIV001 DRUG

Orally administered for 8 weeks

LIV001

Placebo DRUG

Orally administered for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Liveome Inc.: lead

Study Sites (1)

Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

Wroclaw, Poland

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Piotr Napora, Doctor of Medicine

  Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Hyun-Ja Ko, Doctor of Philosophy

CONTACT

+82-31-8065-8216; sophieko@liveome.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: March 24, 2025
• Primary Completion: January 17, 2026
• Study Completion: March 24, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)