AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Randomized, Double-Blind, Placebo Controlled, Multi - Center, Phase 1b Study to Evaluate the Safety and Tolerability of LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis

This research study is for adults, aged 18 and over, who have a condition called mild to moderate active ulcerative colitis. Researchers want to find out if a new medicine, called LIV001, is safe for people to use and how well their bodies react to it. This is a very early stage of testing, often called a 'Phase 1b' study. To make sure the results are reliable, some participants will receive the new medicine, while others will get a 'dummy' medicine (called a placebo) that looks the same but contains no active ingredients. Neither the patient nor their doctor will know who is getting which. This helps researchers understand the true effects of LIV001. The study is being carried out in several different medical centres.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Liveome Inc.

Enrolment target

Start

18 Nov 2024

mild-to-moderate active ulcerative colitis

What is this study about?

This study is designed for individuals who have mild to moderate active ulcerative colitis. Ulcerative colitis is a long-term condition where the lining of the large bowel and rectum becomes inflamed. 'Active' means your symptoms are currently flaring up. Early-stage studies like this one are crucial because they help us understand if new treatments are safe for people to take and if they cause any unwanted side effects. The information gathered from this study will help determine if it's safe to test LIV001 in larger groups of patients in the future.

The main goal is to look at the safety of LIV001. This includes seeing if it causes any side effects and how easily people's bodies handle the new medicine. Because this is an early study, researchers are not primarily looking at whether the medicine cures ulcerative colitis, but rather ensuring it's safe enough to continue researching.

To get the clearest results, the study is 'randomized,' meaning volunteers are randomly assigned to either receive LIV001 or a 'placebo' (a dummy medicine). It's also 'double-blind,' which means neither you nor your study doctor will know whether you are receiving LIV001 or the placebo. This helps prevent anyone's expectations from influencing the results. The study is also taking place in several different medical centres, which can help ensure the findings are broadly applicable.

Key takeaways

This study is testing a new medicine (LIV001) for mild to moderate active ulcerative colitis.
It's an early-stage study focusing on safety and how well the body tolerates the medicine.
Participants will be randomly assigned to receive either LIV001 or a dummy medicine (placebo).
Neither you nor your doctor will know which treatment you are receiving.
The study is for adults aged 18 and over, both men and women.
Your health will be closely monitored throughout your participation.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. The key requirement is that you have been diagnosed with mild to moderate active ulcerative colitis. This means your condition is currently causing symptoms, but these symptoms are not extremely severe.

There might be other specific health conditions or medications that would prevent someone from joining, which the study team will discuss with you. These are put in place to ensure the safety of everyone taking part and to make sure the study results are as clear as possible.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of ulcerative colitis?
Is your ulcerative colitis currently causing symptoms (active)?
Are your ulcerative colitis symptoms considered mild to moderate (not severe)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you will have regular visits to the study centre. These visits will involve health checks, blood tests, and possibly other assessments related to your ulcerative colitis. You'll be given either the new medicine (LIV001) or a dummy medicine (placebo) to take as instructed.

The study team will keep in close contact with you to monitor your health and any changes you experience. After you stop taking the study medicine, there will be a follow-up period to ensure your well-being. The total length of your participation, including treatment and follow-up, will be explained in full by the study team.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as contributing to medical knowledge that could help future patients with ulcerative colitis, and you'll receive careful medical monitoring. However, there's no guarantee the new medicine will help your condition, and there's a chance you might experience side effects, just like with any medicine. The study team will explain all known or potential risks in detail. Remember, you can always change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Poland

Common questions

What is 'mild to moderate active ulcerative colitis'?

It means your ulcerative colitis is currently causing symptoms, but they are not the most severe form of the condition.

What does 'Phase 1b' mean?

It means this is an early stage of testing a new medicine in people, mainly to check if it's safe and how the body handles it.

What's a 'placebo'?

It's a dummy medicine that looks like the real thing but has no active ingredients. It helps researchers compare the new medicine's effects.

Will I know if I'm getting the new medicine or the placebo?

No, neither you nor your study doctor will know. This is called 'double-blind' and helps keep the study fair.

Can I stop participating if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.