A study to evaluate the safety and tolerability of JNJ-90106848 and to investigate how long JNJ-90106848 stays in and acts on the body (pharmacokinetics) and how the body responds to JNJ-90106848 (pharmacodynamics) when injected into healthy volunteer participants
This study is an early research trial, known as a Phase 1 study, testing an experimental drug called JNJ-90106848 for the very first time in humans. The medicine is being developed to potentially treat long-term inflammatory conditions, where the body's immune system mistakenly attacks healthy tissue. Before testing new medicines in people who are unwell, doctors first give them to healthy volunteers. The main goal of this study is to check whether JNJ-90106848 is safe, how well people tolerate it, and whether it causes any unwanted side effects. Researchers will also measure how long the medicine stays in the bloodstream and how the body processes it. Taking part involves receiving the study drug as an injection and having regular health checks, blood tests, and medical monitoring by a specialist research team.
At a glance
What is this study about?
Inflammation is a normal process that helps your body fight off illness and heal from injuries. However, in some long-term conditions, the immune system becomes overactive and causes swelling, pain, and damage to healthy tissue. Researchers are working on new treatments to help calm this harmful inflammation, and this clinical trial is looking at an experimental medicine called JNJ-90106848.
This trial is a 'first-in-human' Phase 1 study. That means it is the first time this medicine is being given to people rather than tested in a laboratory. The primary aim is to check the medicine's safety. Doctors want to see how the human body reacts to the injection, how long the drug remains active, and whether it causes any side effects.
To get the clearest picture of how a new medicine works without interference from existing health problems, Phase 1 studies usually recruit healthy volunteers. The results from this study will help scientists decide if the drug is safe enough to move on to larger trials involving patients who live with inflammatory diseases.
Key takeaways
- This is a Phase 1 trial testing a new medicine, JNJ-90106848, in humans for the first time.
- The study is looking for healthy adult volunteers aged 18 and older.
- The main purpose is to test the safety of the drug and see how the body processes it.
- The medicine is given by injection at a specialist clinic.
- Taking part is voluntary, and participants are closely monitored by medical staff throughout.
Who may be eligible?
This trial is open to adults aged 18 and over who are generally in good health. Because this is a safety study, researchers are looking for healthy volunteers rather than people currently living with an illness.
To take part, you will need to undergo medical checks to confirm you are fit and well. Having certain long-term medical conditions, taking regular prescription medicines, or having a history of severe allergies may mean you cannot join the study.
Women who are pregnant or breastfeeding, or people planning a pregnancy during the trial period, are usually not able to take part. The study team will review your full medical history to make sure joining is safe for you.
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 consider myself to be in good general health.
- I do not have any serious or long-term medical conditions.
- I am not currently pregnant or breastfeeding.
- I am able to attend clinic visits and have regular blood tests.
What does participation involve?
If you decide to join this trial, you will first attend a screening visit where doctors check your overall health using blood tests, heart traces (ECGs), and physical exams. If you are eligible, you will receive the study medicine, JNJ-90106848, given as an injection.
Because this is an early safety study, you may need to stay at a specialist clinical research unit for a short period so the medical team can monitor you closely. During your stay and at follow-up visits, doctors will regularly take blood and urine samples to see how your body breaks down and clears the medicine. You will also have regular checks on your blood pressure, temperature, and heart rate. The study team will explain the exact schedule of clinic visits and how many weeks the follow-up period will last before you agree to take part.
Potential risks and benefits
Locations (1)
- —UnverifiedBelgium
Common questions
What is a Phase 1 clinical trial?
A Phase 1 trial is the earliest stage of testing in humans. It focuses on finding out if a medicine is safe, checking for side effects, and seeing how the body handles it.
Will I get paid for taking part?
Healthy volunteer studies in the UK usually offer payment to compensate you for your time, travel, and the inconvenience of attending clinic visits.
How is the medicine given?
The medicine is given as an injection, which may be into a vein (intravenously) or under the skin (subcutaneously). The study doctor will explain the exact method.
What happens if I feel unwell during the trial?
Doctors and nurses will be on hand to monitor you closely. If you develop any symptoms, you will receive immediate medical care and advice.
Can I leave the study if I change my mind?
Yes. Taking part is entirely your choice. You are free to withdraw at any stage without having to give an explanation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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