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

NCT05975047 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2024-12-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Liveome Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-24
Primary Completion
2024-03-05
Completion
2024-03-05

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05975047 on ClinicalTrials.gov