RecruitingPHASE1INTERVENTIONAL

A Study to Investigate the Safety of GSK4024484 in Healthy Adult Participants

This study is investigating a new medicine called GSK4024484, which might help treat a type of malaria called Falciparum malaria. The main goal is to understand how safe this new medicine is in healthy adults aged 18 to 60. Researchers also want to see how taking the medicine with or without food changes how it works in the body. This is a very early stage (Phase 1) study, focusing on safety and how the body handles the medicine, rather than treating malaria itself. Participants will receive either the study medicine or a placebo (a dummy medicine) to help scientists compare the effects.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

156

Start

11 Dec 2023

Estimated completion

07 Aug 2026

Malaria, Falciparum

What is this study about?

This study is looking into a new medicine, called GSK4024484, that scientists hope could one day help treat a type of malaria. Malaria is a serious illness spread by mosquitoes, and new treatments are always needed to fight it.

The main purpose of this particular study is to check how safe GSK4024484 is when healthy adults take it. It's a very early step in developing new medicines. Think of it like testing a new car engine for safety and how it performs in different conditions, rather than testing the whole car on the road.

Researchers also want to understand how the body deals with the medicine. For example, they'll check how much medicine gets into your system and how quickly, and if eating food before or after taking the medicine makes a difference. This information helps them decide the best way for people to take the medicine in the future.

Key takeaways

This study is testing a new malaria medicine in healthy adults.
The main goal is to check how safe it is and how the body uses it.
It's a very early-stage study, not a treatment for malaria itself.
You might receive the new medicine or a dummy pill (placebo).
Close medical checks will be done throughout the study.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 60 years old. You'll have a thorough health check-up, including blood tests and a heart check, to make sure you're fit and well enough to take part.

There are also some specific health requirements. For example, certain liver tests need to be within a normal range, and your weight needs to be in a healthy range (BMI between 19 and 32). Both men and women who cannot become pregnant are welcome.

However, you can't join if you have certain existing health problems, especially those affecting your heart, lungs, liver, kidneys, or stomach, or if they could change how your body handles medicines. You also can't take part if you drink more than 14 units of alcohol per week. The doctors leading the study will carefully review your health to make sure it's safe for you to participate.

Quick self-check

Are you between 18 and 60 years old?
Do you consider yourself generally healthy?
Do you have a healthy weight (BMI between 19 and 32)?
Are you a woman who can't become pregnant, or a man?
Do you have no history of serious heart, lung, liver, or kidney problems?
Do you drink less than 14 units of alcohol per week?

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 be given either the new study medicine, GSK4024484, or a placebo (a harmless dummy pill that looks like the real medicine). You won't know which one you're getting, and neither will the study team, to keep the results fair.

The study involves regular visits to the clinic where doctors and nurses will monitor your health closely. This will include physical exams, blood tests, and heart checks to make sure you're safe and to see how your body reacts to the medicine. You may also be asked to follow specific instructions about eating before taking the medicine, to help understand how food affects it. The total time you'd be involved in the study would be explained to you in detail before you make any decision.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is helping science develop new medicines that could one day treat serious diseases like malaria. You would also receive close medical attention and health monitoring throughout the study. Potential risks could include unexpected side effects from the study medicine, though this study is specifically designed to assess safety in healthy people. You will be fully informed of all known potential risks before you agree to take part. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

GSK Investigational Site
Cambridge, United Kingdom· Recruiting

Common questions

What is GSK4024484?

It's a new medicine being developed to potentially treat a type of malaria called Falciparum malaria.

Why is this study in healthy people?

This is a very early study (Phase 1) to mostly check how safe the medicine is and how the body handles it before it's given to people with malaria.

What is a placebo?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps compare the effects fairly.

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

No, neither you nor the study team will know during the study. This helps ensure fair and accurate results.

How long will I be in the study if I join?

The exact duration will be explained to you, but studies like this usually involve several visits over a few weeks or months.

How to find out more

US GSK Clinical Trials Call Center

GSKClinicalSupportHD@gsk.com 877-379-3718 Official trial record

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