Active not recruitingPHASE1INTERVENTIONAL

A First-time in Human (FTIH) Study to Evaluate Safety, Tolerability, Pharmacokinetics and Target Engagement of GSK4528287 in Healthy Participants

This study is about a new medicine called GSK4528287, which is being developed to help treat inflammatory bowel conditions such as ulcerative colitis. This is the first time this medicine will be given to people. The main goals are to check if it's safe, how well healthy volunteers can tolerate it, and how their bodies process the medicine. We'll also look at whether it starts to work as intended. Participants will receive a single dose of the medicine, starting with a very low dose for the first group, which will be gradually increased for following groups. This carefully controlled approach helps us learn about the medicine step by step.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

Start

18 Nov 2024

Estimated completion

25 Feb 2027

Colitis, Ulcerative

What is this study about?

This study is an early but very important step in developing a new medicine, called GSK4528287, for conditions like ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease that causes long-lasting inflammation and sores in the lining of the large intestine.

Because this is the very first time this medicine will be given to people, the main things we want to find out are whether it's safe to use and how well people can tolerate it. We'll also be looking at how the medicine moves through and is processed by the body, and if it starts to affect the body in the way we hope it will. By understanding these things, we can make decisions about further studies.

Healthy volunteers will be given a single, small dose of the medicine to start with. If that goes well, later groups of volunteers might receive slightly higher doses. This careful, step-by-step approach helps us gather information safely and understand the potential of GSK4528287.

Key takeaways

It's a very early study for a new medicine for bowel conditions.
The main goal is to check for safety and how the body handles the medicine.
Healthy volunteers between 18 and 55 are needed.
Participants will receive a single dose of either the medicine or a placebo.
Close medical monitoring will be involved.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 55 years old. This means you shouldn't have any major health issues that could affect the study results or put you at risk. We'll check your health with medical examinations, blood tests, and heart monitoring.

You also need to meet specific health requirements like having healthy blood cell counts and a normal heart tracing (ECG). If you're a woman, you must not be able to have children. If you're a man, you'll need to agree to use contraception and avoid donating sperm for a certain period after taking the medicine.

We'll also need you to be up to date with your COVID-19 vaccinations and have a negative COVID-19 test before starting. If the study takes place during flu season (October to April), we'll ask you to have had a flu vaccine at least 30 days before receiving the study medicine, or get one if you haven't already.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 55 years old?
Are you generally healthy with no major medical conditions?
Are you a woman who cannot have children, or a man willing to use contraception?
Are your weight and body mass index (BMI) within a healthy range?
Are you up to date with your COVID-19 vaccinations?

Answer every question to see your result.

What does participation involve?

As this is a first-time-in-human study, participation would likely involve spending some time at the research clinic or hospital for assessment and monitoring. You would receive a single dose of either the study medicine (GSK4528287) or a placebo (a dummy medicine with no active ingredients). There will be several check-ups before, during, and after taking the medicine. These check-ups will include physical exams, blood tests to measure the medicine's levels and see how your body is responding, and heart recordings. The exact number of visits and the full duration of your involvement will be explained in detail.

Potential risks and benefits

Participating in research studies like this can have some potential benefits, such as contributing to medical knowledge that could help future patients with conditions like ulcerative colitis. However, as this is a new medicine, there are also potential risks, including unknown side effects. We don't expect any direct health benefits for you personally as a healthy volunteer. All tests used in the study carry minimal risks. You will be closely monitored for any unwanted effects. Importantly, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

GSK Investigational Site
Verified postcode
Cambridge, United Kingdom

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-lasting condition where the lining of the large intestine (colon and rectum) becomes inflamed and develops small sores, causing symptoms like tummy pain and diarrhoea.

What does 'first-time in human' mean?

It means this is the very first time this specific medicine has been given to people. It's a key step to see if it's safe and how the body handles it before it can be tested in patients.

Will I definitely get the new medicine?

No, you might receive the new medicine (GSK4528287) or a placebo, which is a dummy medicine with no active ingredients. This helps researchers compare the effects.

Why are healthy people needed for the study?

Testing new medicines in healthy people first helps us understand how the medicine behaves in a body that isn't already affected by an illness, making it easier to spot any side effects.

Will I get paid for taking part?

Information about payment for participation, if any, details of which are not provided in this summary, would be discussed with you by the research team.