Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A study to evaluate the safety and tolerability of JNJ-70035108 and to evaluate how long JNJ-70035108 stays in and acts on the body (pharmacokinetics) when given as single and repeated doses to healthy participants

This study is looking at a new medicine, code-named JNJ-70035108. It's designed for people with conditions that cause inflammation in the body. For this first step, however, we're inviting healthy adult volunteers to take part. The main goals are to find out if the medicine is safe and well-tolerated, meaning it doesn't cause too many problems. We also want to understand how the medicine moves through and stays in the body over time. This will involve giving volunteers either a single dose or several doses over a period. This type of study is an early but very important step in developing new medicines.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Janssen Cilag International

Enrolment target

Start

10 Sep 2024

Inflammatory Conditions

What is this study about?

This study is an early but very important part of finding new ways to treat inflammatory conditions. These are conditions where the body's immune system mistakenly attacks its own tissues, leading to pain, swelling, and other problems. The new medicine, known as JNJ-70035108, is being developed to help manage these conditions.

Because this is a brand-new medicine that hasn't been widely studied in humans before, the very first step is to test it in healthy volunteers. This helps us ensure that the medicine is safe for people and understand how it works in the human body before we test it in people who are unwell. This is a standard and necessary part of developing any new medication.

Throughout the study, we will be carefully checking how your body reacts to the medicine, both after a single dose and after you've taken it several times. This includes looking for any side effects and seeing how long the medicine stays in your system. This information is crucial for future studies and for deciding the right dosage if the medicine proves to be helpful.

Key takeaways

This is a very early-stage study for a new medicine.
It's designed for healthy adult volunteers.
The main goal is to check the medicine's safety and how it works in the body.
It's for potential treatment of inflammatory conditions.
Participation involves medical checks and receiving the study medicine.

Who may be eligible?

This study is looking for healthy adults. This means you need to be at least 18 years old.

Because we need to check how the new medicine works without other health conditions getting in the way, generally, people who are healthy and don't have any major ongoing illnesses are considered for this type of trial.

Specific medical details, including any medicines you are currently taking, will be checked carefully by the study team. This is to make sure the study is safe for you and that the results will be clear.

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 at least 18 years old?
Are you generally in good health?
Are you able to attend regular clinic visits?
Are you not currently taking any medicines that might interfere with the study?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would first have a full health check-up to make sure it's safe for you. You would then be given the study medicine, JNJ-70035108, either as a single dose or several doses over a set period. You would need to attend regular visits at the study clinic. These visits would involve various tests like blood tests, urine tests, and possibly heart checks (like an ECG) to monitor how your body is reacting to the medicine. You would also be asked about any side effects you might experience. The total length of your participation, including follow-up, would depend on whether you receive single or repeated doses, and the study team will explain this in full detail.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as contributing to scientific knowledge that could help future patients with inflammatory conditions. You will also receive careful medical monitoring throughout the study. However, like all medicines, JNJ-70035108 might cause side effects, some of which might not be known yet. The study team will explain all known potential risks before you decide to participate. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What kind of medicine is JNJ-70035108?

It's a new medicine being developed to treat conditions that cause inflammation in the body.

Why is the study being done in healthy people first?

This is a very early study to check if the new medicine is safe and how it works in the body before testing it in people who are unwell.

What does 'single and repeated doses' mean?

It means some people might get one dose of the medicine, while others might get it several times over a period, so researchers can see how the body reacts.

What is 'Phase I' of a clinical trial?

Phase I means it's one of the very first times the medicine is being given to people. It mainly focuses on safety and how the body handles the medicine.

Will I get paid to be in the study?

Details about compensation for time and travel will be discussed by the study team if you are eligible and interested.