RecruitingPHASE1INTERVENTIONAL

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB5285 in Healthy Study Participants

This research is investigating a new medication called UCB5285. The main goal is to find out if it's safe to use and how well healthy people tolerate different doses. We also want to understand how the body processes the medicine, including how much of it gets into the system and how quickly it's removed. The study includes healthy volunteers from various backgrounds, specifically looking at healthy individuals of Japanese origin as well. This is an early-stage study, often called a Phase 1 trial, where new medicines are first tested in humans in small doses to check for any unexpected side effects and to get a basic understanding of how they work in the body before moving on to larger studies.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

UCB Biopharma SRL

Enrolment target

Start

08 Dec 2025

Estimated completion

13 Dec 2026

Healthy Participants

What is this study about?

This study is an important early step in developing a new medicine called UCB5285. Imagine that before a car is sold to the public, it needs to go through many safety tests. This is similar, but for a medicine. We are testing UCB5285 in healthy volunteers to understand two main things: first, is it safe? We want to see if it causes any unwanted side effects and how well people can handle different amounts of it. Second, we want to learn how the body deals with the medicine. This involves understanding how it's absorbed, how it moves around the body, and how it's eventually removed. This information is crucial for deciding the right dose and understanding its potential future use.

This type of study is called a 'Phase 1' trial. It's usually the first time a new medicine is given to humans. Because we don't know much about UCB5285 yet, we start with very small doses and slowly increase them while carefully watching participants. The main focus at this stage is always safety, not checking if the medicine treats a specific illness. We also want to see if there are any differences in how people of Japanese origin handle the medicine compared to others.

The information gathered from this study is vital. It helps scientists and doctors understand if it's safe enough to continue researching and potentially moving to later stages of development where it might be tested in people with specific health conditions. By taking part, healthy volunteers are making a significant contribution to medical science and helping to potentially bring new treatments to those who need them in the future. Remember, participating is always your choice.

Key takeaways

This study is about testing the safety of a new medicine called UCB5285.
It's an early-stage study in healthy volunteers, including those of Japanese background.
Participants will receive either the active medicine or a placebo (dummy drug).
Your health will be carefully checked throughout the study.
You won't get any direct health benefits, but you'll help medical science.
You can stop participating at any time without any reason.

Who may be eligible?

To join this study, you need to be a healthy adult aged between 18 and 55 years old. This means you shouldn't have any major ongoing health problems, and you'll have a thorough check-up by a doctor to make sure you're fit enough. We'll check your medical history, do a physical exam, take some blood tests, and check your heart. Your weight also needs to be between 40 and 110 kilograms, and your Body Mass Index (BMI) should be between 18 and 30.

We're also looking for some healthy participants of Japanese origin. This means you would have been born in Japan, have both parents and all four grandparents born in Japan, and haven't had big changes to your lifestyle or diet since leaving Japan, if applicable.

There are also some reasons why you wouldn't be able to join. For example, if you have a serious medical condition past or present (like a significant heart problem, kidney problem, or a serious mental health issue) that could affect how you react to the medicine or make it unsafe for you. You also couldn't join if you've had a significant infection (like a serious bacterial or viral one) in the last six months, or if you have a known allergy to similar types of medicines (called monoclonal antibodies).

Quick self-check

Are you between 18 and 55 years old?
Do you generally feel healthy with no serious medical problems?
Is your weight between 40kg and 110kg and your BMI between 18 and 30?
Have you not had a serious infection in the last 6 months?
Do you not have any known serious allergies to similar types of medicines?
If you are of Japanese origin, were you born in Japan with both parents and all four grandparents also born in Japan?

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'll first have screening appointments to check if you're suitable. This involves medical exams, blood tests, and heart checks. If you qualify, you'll receive either the study medicine, UCB5285, or a placebo (a dummy medicine with no active ingredient). You won't know which one you're getting. You'll take the medicine in increasing doses, meaning you'd start with a small amount and, if safe, gradually receive slightly higher doses.

Throughout the study, you'll have regular visits to the clinic where doctors and nurses will monitor your health very closely. They'll do physical exams, take more blood and urine samples, and check your vital signs like blood pressure and heart rate. You might need to stay at the clinic for certain periods after taking the medicine so staff can watch you carefully. The total duration of your involvement, including all visits and follow-up, will be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a study like this might have potential benefits for others in the future, as you'd be helping scientists learn more about a new medicine. There's no direct personal health benefit for you, as the medicine isn't designed to treat a specific illness in healthy people. As with any new medicine, there are potential risks, including side effects that we don't yet know about. These could range from mild discomfort to more serious reactions. The study team will explain all known potential risks in detail, and your health will be carefully monitored. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Up0161 1001
Harrow, United Kingdom· Recruiting

Common questions

What is UCB5285?

UCB5285 is a new medicine that is being tested for the first time in people. We want to find out if it's safe and how the body handles it.

Will I get the actual medicine or a dummy pill?

You might get the actual medicine (UCB5285) or a placebo (a dummy medicine with no effect). You won't know which one you're receiving.

Do I have to pay to join the study?

No, you don't have to pay to join. In fact, you might be compensated for your time, travel, and inconvenience.

What if I feel unwell during the study?

The study team will monitor you very closely. If you feel unwell at any point, you should tell them immediately. Your safety is their top priority.

Can I leave the study at any time?

Yes, absolutely. You can choose to leave the study at any point, for any reason, without needing to explain why. This will not affect your routine medical care.

How to find out more

UCB Cares

ucbcares@ucb.com +18445992273 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.