RecruitingPHASE1INTERVENTIONAL

Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants

This research study is investigating a new potential malaria treatment called MMV055. It's a Phase 1 study, meaning it's one of the first times this medicine will be given to people. The main goals are to check its safety, how well people tolerate it, and how it's processed by the body when given as a single injection. Researchers will test MMV055 on its own and in combination with another experimental medicine, MMV371. Healthy adults will take part, receiving either the active medicine or a dummy treatment (placebo). This important early stage helps us understand if MMV055 has potential for future development as a treatment for malaria, a serious infection prevalent in many parts of the world.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Medicines for Malaria Venture

Enrolment target

Start

30 Jun 2025

Estimated completion

02 Dec 2027

Malaria, Falciparum

What is this study about?

This study is about finding new ways to fight malaria, a serious disease spread by mosquitoes. Researchers are testing a new medicine called MMV055. This is a very early-stage study, known as Phase 1, which means it's one of the first times this medicine is being given to people. The main purpose is to carefully check if the medicine is safe and well-tolerated when given as a single injection. They also want to understand how the medicine moves through and is cleared from the body. This information is crucial for deciding if MMV055 can be developed further.

The study will look at MMV055 in two ways: first, on its own at different dose levels, and then in combination with another experimental malaria medicine called MMV371. By testing both, scientists can get a better idea of its effects. Healthy volunteers will be randomly assigned to receive either the active medicine or a placebo (a dummy injection that looks like the real thing but contains no medicine).

The study is 'blinded', which means neither you nor the study team will know if you've received the active medicine or the placebo. This helps ensure the results are as unbiased as possible. The information gathered from this study will be vital in deciding if MMV055 has the potential to become an effective medicine for treating malaria in the future.

Key takeaways

This study is testing a new malaria medicine (MMV055) in healthy adults.
It's a Phase 1 study, focused on safety, side effects, and how the body handles the medicine.
Participants will receive either the active medicine or a placebo via injection.
The study involves regular health checks, blood tests, and heart monitoring.
Your participation could help develop future malaria treatments.

Who may be eligible?

To join this study, you must be a healthy adult aged between 18 and 60. You should be willing to participate fully and follow all study instructions. If you are a woman, you must not be pregnant or breastfeeding, and for some parts of the study, women who can have children will need to use effective birth control. Your overall health will be checked by a doctor to make sure you're well enough to take part, including checks on your heart, blood pressure, and other body functions.

There are certain reasons why you might not be able to join. For instance, if you have severe allergies to any medicines, or a history of serious health conditions affecting your heart, kidneys, liver, lungs, or digestive system, you would likely not be suitable. Certain blood pressure readings or heart beat abnormalities would also prevent you from participating. Your general health and any existing medical conditions are very important for your safety during the study, so these will be carefully reviewed.

Quick self-check

Are you between 18 and 60 years old?
Are you generally healthy with no serious existing medical conditions?
Are you willing and able to attend all study appointments and follow instructions?
If you are a woman, are you not pregnant or breastfeeding, and willing to use birth control if required?
Do you have a Body Mass Index (BMI) between 19.0 and 30.0 kg/m2?
Do you NOT have serious known allergies to medicines?

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

What does participation involve?

If you decide to participate, you will receive a single injection of either the study medicine (MMV055, or MMV055 with MMV371) or a placebo. You won't know which one you receive, and neither will the study team. You'll have regular check-ups and assessments, which include physical examinations, blood and urine tests, and heart monitoring (ECGs) to make sure you're safe and to track how the medicine affects your body. Your vital signs, like blood pressure and heart rate, will also be regularly checked. There will be initial appointments, the dosing day, and follow-up visits over several weeks to monitor you. The total duration of your participation will depend on the specific part of the study you are in, but the follow-up period could last up to 48 weeks.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and potential risks. You might not directly benefit from this study, but your participation could help researchers learn more about a potential new treatment for malaria, which could help many people in the future. Potential risks include side effects from the study medicine, which could range from mild to more serious, or discomfort from injections and blood tests. You will be closely monitored for any reactions. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Quotient Sciences
Nottingham, United Kingdom· Recruiting

Common questions

What is a Phase 1 study?

Phase 1 studies are the first stage of testing a new medicine in people. They focus on whether the medicine is safe, what side effects it might have, and how the body handles it.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the active medicine against no medicine.

Will I know if I'm getting the actual medicine?

No, this study is 'blinded,' meaning neither you nor the study staff will know whether you receive the active study medicine or the placebo. This helps ensure fair and unbiased results.

What is malaria?

Malaria is a serious disease caused by parasites and spread through the bites of infected mosquitoes. It can cause high fevers, chills, and flu-like illness, and can be life-threatening if not treated.

Can I leave the study if I change my mind?

Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care or your relationship with the study team.

How to find out more

Stephan Chalon, MD, PhD

chalons@mmv.org +41 22 555 03 00 Official trial record

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