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

A Study to Evaluate the Safety and Tolerability of JNJ-77730614 When Given as Single and Multiple Doses to Healthy Participants to Assess How Long JNJ 77730614 Stays in the Body (Pharmacokinetics) and How the Body Responds to it (Pharmacodynamics)

This is an early-stage study, meaning it's one of the first times this new medicine, JNJ-77730614, is being given to people. The main goals are to check if the medicine is safe and if healthy people can tolerate it well. We also want to understand how the medicine moves through and stays in the body, and how the body responds to it. This information helps us learn more about the new medicine before it can be tested in people with specific conditions. Your participation as a healthy volunteer is really important for this initial step in developing new treatments. This study will help us understand if the medicine might be promising for future research.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Janssen - Cilag International

Enrolment target

Start

29 Sep 2023

Healthy Volunteers

What is this study about?

This research is focused on a new medicine known as JNJ-77730614. Think of this as the very first step in checking out a new medicine in people. Before any new medicine can eventually help patients with illnesses, scientists first need to make sure it's safe enough to be given to people. This is where healthy volunteers, like those taking part in this study, play a crucial role.

Specifically, the main things we want to learn are: Is JNJ-77730614 safe when healthy people take small amounts, and also when they take it over a short period? We also want to understand how the medicine behaves inside the body. This includes looking at how quickly the body absorbs the medicine, how long it stays in the system, and how the body processes and gets rid of it. This is often called 'pharmacokinetics.' We'll also check how the body reacts to the medicine, which is sometimes called 'pharmacodynamics.'

By carefully studying healthy volunteers, we can gather important basic information about this new medicine. This helps researchers decide if it's safe enough to continue testing in later studies, which would involve people who might actually benefit from the medicine for a specific health condition. Your help in this early stage is essential for future medical advancements.

Key takeaways

It's an early-stage study of a new medicine (JNJ-77730614).
The main goals are to check the medicine's safety and how the body reacts to it.
Only healthy adults, aged 18 and older, can take part.
Both men and women are welcome to participate.
Your contribution helps in the development of future medicines.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you must be at least 18 years old. There is no upper age limit, meaning older adults can also participate as long as they meet the other health criteria.

Both men and women are welcome to join this study. The most important thing is that you are generally healthy. This means you shouldn't have any major ongoing health conditions that could affect how the medicine works or put your health at risk during the study.

Before you can join, a study doctor and nurse will carefully check your health to make sure you are suitable. They will ask about your medical history and do some examinations to confirm you are healthy enough for the study.

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.

Am I at least 18 years old?
Do I consider myself to be generally healthy?
Do I have any ongoing major health conditions?
Am I comfortable with regular blood tests and medical check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, JNJ-77730614. You might receive it as a single dose initially, and then possibly multiple doses over a period. The study team would closely monitor your health during this time. This would involve regular visits to the clinic, where you would have various assessments. These assessments could include blood tests, urine tests, checking your heart rate and blood pressure, and asking you about how you are feeling. The exact number of visits, how long each visit lasts, and the total duration of your participation in the study would be explained in detail by the study team. You would also have a follow-up period after you finish taking the medicine to ensure you are well.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this study, you might not directly benefit from the medicine yourself, as it's an early-stage study in healthy people. However, you would be contributing valuable information that could help develop new medicines for others in the future. Potential risks might include feeling unwell from the study medicine, mild side effects, or discomfort from medical procedures like blood tests. All known risks will be fully explained before you agree to take part. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your 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 is JNJ-77730614?

It's a new medicine that is being tested for the first time in people to learn about its safety and how it works in the body.

Why is this study done on healthy volunteers?

Testing new medicines on healthy volunteers first helps us understand how the medicine works in a typical body and if it's safe before trying it on people with specific health problems.

Will I get paid for taking part?

This information is not provided in the brief. You should ask the study team if there is any payment or reimbursement for your time and travel.

What does 'Human Pharmacology (Phase I)' mean?

This means it's an early-stage study, often the very first time the medicine is given to people, to check its safety and how the body handles it.

What happens if I change my mind?

Your participation is voluntary. You can choose to leave the study at any point, and you don't need to give a reason. This won't affect any future medical care you receive.