A study to investigate JNJ-80202135 (nipocalimab) delivered subcutaneously via prefilled syringe autoinjector and via normal syringe
This research study is about a new way to give a medicine called nipocalimab. Instead of a traditional injection, researchers are exploring two new methods: a pre-filled pen device (called an autoinjector) and a regular syringe. The main goal is to see how safe these new injection methods are and how well the body handles the medicine when given this way. This study is for healthy adult volunteers, meaning people who don't have known health problems. By testing in healthy volunteers, researchers can get a good idea of how the medicine works on its own without other health conditions affecting the results.
At a glance
What is this study about?
This research is looking into a medicine called nipocalimab, and specifically how it can be given to people. Currently, doctors are interested in finding the most convenient and easiest ways for patients to receive their medications. This study focuses on giving nipocalimab as an injection under the skin, similar to how many people with diabetes give themselves insulin.
The study will compare two different ways of giving this injection. One way is using a 'pre-filled syringe autoinjector'. This is a pen-like device that makes it easier to inject the medicine yourself. The other way is using a 'normal syringe', which is a more traditional needle and syringe. The main purpose of this study is to see if both methods are safe and if the medicine is absorbed correctly into the body.
This kind of study is called a 'Phase I' study, which means it's one of the first times a new medicine or a new way of giving a medicine is tested in people. Because it's an early-stage study, it focuses on healthy volunteers rather than people with a specific illness. This helps researchers understand the basic safety and how the medicine behaves in the body without other health conditions getting in the way. If these injection methods prove safe and effective, it could make this medicine easier to use for future patients.
Key takeaways
- This study is testing new ways to inject a medicine called nipocalimab.
- It's an early-stage study for healthy adults.
- Researchers want to see if pre-filled pens and normal syringes are safe and effective for giving the medicine.
- Participation involves injections, health checks, and clinic visits.
- It aims to make future medicines easier to use for patients.
Who may be eligible?
This study is looking for volunteers who are healthy adults. This means you shouldn't have any major health conditions or be taking medicines that could interfere with the study.
To join, you must be at least 18 years old. There isn't an upper age limit mentioned, but generally, participants need to be in good overall health. Both men and women are welcome to take part in this research.
The research team will carry out some health checks to make sure it's safe for you to participate and that you meet all the specific requirements.
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 18 years old or older?
- Do you consider yourself generally healthy?
- Are you able to attend several clinic visits?
- Are you comfortable with injections and blood tests?
- Are you willing to follow study instructions carefully?
What does participation involve?
If you decide to take part, you will be given the study medicine, nipocalimab, as an injection under your skin. You'll receive this medicine using either a pre-filled pen device designed for easy injection or a traditional syringe, depending on what the study assigns you to. The study will involve several visits to a clinic over a period of time. During these visits, the research team will conduct various assessments. These might include blood tests, urine tests, physical examinations, and asking you questions about how you are feeling. The aim is to monitor your health closely and see how your body reacts to the medicine and the different injection methods. You will be given clear instructions on how to take the medicine and what to expect during your follow-up appointments. The total length of your participation, including all visits and follow-up, will be fully explained before you agree to join.
Potential risks and benefits
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Common questions
What is nipocalimab?
Nipocalimab is a type of medicine that researchers are studying. In this particular trial, they are focusing on how it can be given to patients.
Why is this study only for healthy people?
Early-stage studies often use healthy volunteers to understand how a new medicine behaves in the body and to check for safety without other health problems complicating the results.
What is an autoinjector?
An autoinjector is a pen-like device that helps you give yourself an injection easily and safely under the skin.
Will I get to choose whether I get the autoinjector or the normal syringe?
Usually, in studies like this, participants are assigned to one group or another randomly, meaning by chance, to ensure fair testing. You might not get to choose.
How long will I be in the study?
The exact duration of your participation, including all visits and follow-up, will be explained in full detail by the research team before you join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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