RecruitingPHASE1INTERVENTIONAL

First-in-Human Dose-escalation of GSK4425689A: Safety, Tolerability, and PK in Healthy Adults

This is a very early study, called a Phase 1 trial, for a new medicine named GSK4425689A. It's designed to explore its potential against a type of malaria called Falciparum malaria. We are inviting healthy adult volunteers to take part. The main goals are to check how safe the medicine is, what side effects it might cause, and how the body uses and gets rid of it. We will test two ways of giving the medicine: either directly into a vein (like a drip) or as an injection under the skin (like an insulin shot). Some participants might receive a placebo, which is an inactive substance, to help us compare. This research is a crucial first step in understanding this new medicine before it can be tested in people who have malaria.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

GlaxoSmithKline

Enrolment target

Start

27 Jul 2026

Estimated completion

10 Apr 2028

Malaria, Falciparum

What is this study about?

This study is a very early-stage clinical trial, often called a Phase 1 study. Its main purpose is to carefully check a new medicine, GSK4425689A, which is being developed to potentially help with a serious illness called Falciparum malaria. Malaria is caused by parasites spread through mosquito bites, and Falciparum malaria is the most severe form.

In this initial study, we are inviting healthy adult volunteers to participate. We're not testing if the medicine treats malaria yet; instead, we're focusing on understanding its basic properties. We want to see how safe it is for people, if it causes any unwanted side effects, and how the body processes the medicine – for example, how much of it gets into the blood and how quickly it's removed. We're also comparing two different ways of giving the medicine: either directly into a vein through a drip, or as an injection just under the skin.

Finding new ways to prevent or treat malaria is really important globally. By taking part in this study, volunteers help us gather vital information about this new medicine. This essential first step helps researchers decide if it's safe and promising enough to continue testing in later studies, which would involve people who actually have malaria. Your contribution could help advance medical science.

Key takeaways

This is an early-stage study (Phase 1) for a new malaria medicine.
It aims to check the safety, side effects, and how the body handles the medicine.
Healthy adult volunteers (18-65 years old) are needed.
The medicine is given either into a vein or under the skin; some may receive a placebo.
Participation involves health checks, blood tests, and regular follow-up visits.
Your contribution helps advance research into new malaria treatments.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 65 years old. Your weight should be between 50 and 100 kg, and your Body Mass Index (BMI) should be in a healthy range (18 to 32). This study is open to both men and women, but women must not be able to have children (for example, if they have gone through menopause or had a hysterectomy).

You must be in good overall health, as checked by our medical team. This includes reviewing your medical history, having a physical exam, checking your heart with an ECG, and taking blood and urine samples. Your blood test results for your kidneys, liver, and blood count should be within normal limits, or considered healthy by the study doctor.

It's also important that you understand what the study involves and are able to follow all the instructions, attend all scheduled appointments, and record any information asked of you. Your commitment to these requirements helps us ensure the study is conducted safely and accurately.

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 65 years old?
Do you weigh between 50 and 100 kg?
Are you generally in good health with no significant ongoing medical conditions?
Are you able to attend all study visits and follow instructions?
If you are a woman, are you unable to have children (e.g., post-menopause or had a hysterectomy)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable for the study based on the criteria mentioned. This involves a full health check, including a physical exam, blood tests, and an ECG. If you qualify, you will receive the study medicine, GSK4425689A, in one of the two ways mentioned (into a vein or under the skin), or you might receive an inactive substance (placebo). You won't know which one you receive.

After receiving the medicine, you will have several follow-up visits and may need to stay at the clinic for certain periods to allow the medical team to monitor you closely. During these visits, we will take blood samples to see how the medicine is working in your body and check for any side effects. You'll also have more health checks to make sure you remain well. You'll be asked to accurately record any changes in your health or feelings. The total duration of your participation, including all visits and follow-ups, will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study carries some potential risks. Since this is a new medicine, we don't know all the possible side effects yet, but they will be carefully monitored. You might experience discomfort from injections or blood tests, or other unknown side effects from the medicine. There is no direct personal benefit for you from this study, as it's not designed to treat an illness you have. However, by participating, you are contributing valuable information that could help develop new medicines for malaria, potentially benefiting many people in the future. Remember, 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)

GSK Investigational Site
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is Falciparum malaria?

Falciparum malaria is the most serious and common type of malaria, caused by a parasite spread through mosquito bites. It can be life-threatening if not treated quickly.

What is a 'Phase 1' study?

A Phase 1 study is the first time a new medicine is tested in people. It's mainly to check if it's safe, what side effects it has, and how the body handles it, usually in healthy volunteers.

What is a placebo?

A placebo is a harmless, inactive substance that looks just like the real medicine. Some people get it so we can compare its effects with the actual medicine, helping us understand the medicine better.

Will I get sick from this study?

This study is for healthy volunteers, and the medicine is given in very careful doses. While side effects are possible, your health will be closely monitored by medical staff throughout the study to ensure your safety.

How is the medicine given?

The medicine, GSK4425689A, will be given either directly into a vein (like a drip) or as an injection under the skin (like a small jab).

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.