A study investigating the safety, tolerability, metabolism, and elimination of INE963, a new compound in the treatment of malaria.
Malaria is a serious and sometimes life-threatening infection spread by mosquito bites in tropical countries. Although treatments are available, the parasites that cause malaria can become resistant to existing drugs, making new medicines essential. This clinical trial is testing a new experimental medicine called INE963. It is a Phase 1 study, which means it is the very first time this drug is being given to people. The main purpose is not to cure an active infection yet, but to check whether the medicine is safe, find out what side effects it might cause, and understand how the human body processes and clears it. The trial is open to adults aged 18 and over. Because this is a first-in-human study, doctors will monitor participants very closely to ensure their safety and well-being at all times.
At a glance
What is this study about?
Malaria is a serious illness caused by tiny parasites that get into the blood through mosquito bites. While effective treatments exist, the malaria parasite can change over time and stop responding to current medicines. This is called drug resistance. To stay ahead of the disease and save lives, scientists are constantly working to discover and test new treatments.
INE963 is a brand-new experimental compound designed to attack malaria parasites in a different way. Before any new medicine can be used in clinics or hospitals, it must go through several stages of testing. This trial is a Phase 1 study, representing the very first time INE963 is being given to humans after laboratory tests.
The research team wants to answer several key questions. First, is INE963 safe, and what doses do people tolerate well? Second, what side effects does it cause? Finally, the team will look at the drug's metabolism and elimination—which simply means measuring how quickly the body absorbs the medicine, breaks it down, and removes it through urine or stool.
Because safety is the top priority in any first-in-human trial, participants are watched very carefully by an experienced medical team. The information gathered here will help researchers decide if INE963 can move forward to larger trials that test how well it treats people who are actually ill with malaria.
Key takeaways
- Tests a brand-new experimental malaria medicine called INE963.
- This is a Phase 1 study, meaning it is the first time the drug is given to humans.
- The main goal is to check safety, side effects, and how the body handles the drug.
- Open to adults aged 18 and older who meet the health criteria.
- Participants will be closely looked after by doctors throughout the study.
Who may be eligible?
This study is open to adults aged 18 and over, and both men and women may be able to take part. Because it is a Phase 1 safety trial, studies like this usually look for healthy volunteers rather than people who are currently unwell with malaria.
To join, participants generally need to have good overall health and no major medical conditions that could make taking an experimental drug unsafe. You will also need to be able to attend all clinic appointments and follow the study instructions carefully.
You will likely not be eligible if you have certain chronic health conditions, such as severe heart, liver, or kidney problems. Women who are pregnant, planning to become pregnant, or breastfeeding are usually unable to take part for safety reasons. The research team will review your full medical history before you can join.
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.
- I am at least 18 years old.
- I am generally in good health.
- I am not pregnant or breastfeeding.
- I can attend clinic visits and possibly stay overnight for monitoring.
- I am willing to have regular blood tests and health checks.
What does participation involve?
Taking part usually involves an initial screening visit where doctors check your health with blood tests, urine tests, and a heart tracing (ECG). If you are suitable, you will be given a dose of the study drug, INE963. In many Phase 1 trials, you may need to stay overnight in a specialised clinic for a short period so doctors can check on you regularly. The team will take blood and urine samples over several hours and days to measure how the drug moves through your body. You will also have follow-up visits after leaving the clinic to confirm you are feeling well. The entire study typically lasts a few weeks from your first check-up to the final visit.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
Will this study cure malaria if I have it?
No. This is an early safety trial designed to see how the drug behaves in the body, not to treat active malaria infections.
What does 'first-in-human' mean?
It means this trial is the first time the medicine is being tested in people, after passing laboratory and safety checks.
Will I be paid for my time?
Early-phase trials with healthy volunteers often provide compensation for time and travel expenses. The study team can give you specific details.
What happens if I feel unwell during the trial?
Doctors and nurses will be on hand throughout the study to care for you and treat any side effects right away.
Can I leave the study if I change my mind?
Yes. You can leave the study at any point, and your regular medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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