NCT05975047

A Study of LIV001 in Healthy Subjects and Those with Mild-to-Moderate Active Ulcerative Colitis (UC)

A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of LIV001 in Healthy Subjects and Multiple Doses of LIV001 in Subjects with Mild-to-Moderate Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Liveome Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is only for the first in human phase 1a study designed to investigate the safety and tolerability of LIV001 in healthy participants. LIV001 will be investigated for the safety and efficacy in participants with Ulcerative Colitis (UC) in a phase 1b study.

Detailed description

The study will be conducted in 2 parts. Approximately 36 subjects are planned to be enrolled into the study. * In Part A (SAD), approximately 18 healthy subjects will be enrolled in 2 sequential cohorts (Cohorts SAD1 and SAD2) and randomized 2:1 to receive a single dose of investigational product (IP) (LIV001 or placebo) * In Part B (MAD), approximately 18 healthy subjects will be enrolled into 2 sequential cohorts (Cohorts MAD1 and MAD2) and randomized 2:1 to receive LIV001 or placebo for 14 days. Oversight of the study will be provided by a Safety review committee (SRC) comprising the Principal Investigator (PI), the local Medical Monitor (MM), and a representative of the Sponsor, at a minimum.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	LIV001	Part A- Participants will receive single dose of 280mg capsule on day 1 under fasting conditions; Part B- Participants will receive multiple doses of 280mg capsule from day 1 to day 14 under fasting conditions;
DRUG	Placebo	Participants will receive matching placebo across Part A and B of the study

Timeline

• Start date: 2023-09-24
• Primary completion: 2024-03-05
• Completion: 2024-03-05
• First posted: 2023-08-03
• Last updated: 2024-12-20

Locations

1 site across 1 country: Australia