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Clinical Trials in Poland / NCT06749795
Starting soon Phase 1

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

NCT06749795 · tracked via the Priya Life Science Poland tracker
Sponsor
Liveome Inc
Phase
Phase 1
Started
2025-03-24
Last updated
2025-03-24

Condition(s) studied

Ulcerative Colitis (UC)

Investigational drug(s) / intervention(s)

LIV001Placebo

LIV001: Orally administered for 8 weeks

Placebo: Orally administered for 8 weeks

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska Wroclaw Poland

Other trials for the same condition

A Study of MB-001 in Moderately to Severely Active Ulcerative Colitis Recruiting
Microplastic Analysis in Pediatric Inflammatory Bowel Disease Recruiting
A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) Active, not recruiting
LY4268989 in Adults With Moderately to Severely Active Ulcerative Colitis Recruiting
Development and Validation of a New Paediatric Inflammatory Bowel Disease NUTrition Risk Score (PIBD-NUTS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06749795 on ClinicalTrials.gov ↗ ← All trials in Poland