Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Effects of NT-0796 in Healthy Volunteers and Patients with Parkinson’s Disease

This study is exploring a new medicine called NT-0796. The main goal is to understand how this medicine behaves in the human body and to check if it is safe to use. Researchers are looking for two groups of people: healthy volunteers and individuals who have Parkinson's disease. This is a very early stage of research, often called Phase I. It means scientists are carefully testing the new medicine for the first time in people, rather than looking at how well it treats a condition. It’s an important step to see if the medicine can be developed further in the future. Your participation would help us learn more about this potential new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Nodthera Limited

Enrolment target

Start

12 Apr 2023

Parkinson's Disease

What is this study about?

This research study is about a new medicine, currently known as NT-0796. The main purpose is to learn how our bodies process this medicine and to make sure it's safe for people to take. Think of it like taking a brand new car for its first test drive – we want to see how it handles and if it runs smoothly, rather than seeing how fast it can go just yet.

We are looking for two different groups of people to take part: healthy volunteers who don't have Parkinson's disease, and people who have been diagnosed with Parkinson's disease. Comparing these two groups will help researchers understand how the medicine works differently in healthy bodies versus bodies affected by Parkinson's.

This is a very early stage of medical research, often called human pharmacology or Phase I. This means it's one of the first times this medicine is being given to people. The focus at this stage is primarily on safety and how the medicine moves through and leaves the body, known as its 'pharmacokinetics'. It's a crucial step before the medicine can be tested later on to see if it actually helps treat Parkinson's disease.

Key takeaways

This study is testing a new medicine called NT-0796.
It aims to understand how the medicine works in the body and if it's safe.
Both healthy volunteers and people with Parkinson's disease can join.
It's an early-stage study, focused on safety, not yet on treating the disease.
Participants will be closely checked by doctors and nurses.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults are very welcome to participate as long as they meet the other health requirements.

The study is open to both men and women. We are looking for two types of volunteers: firstly, people who are generally healthy and don't have any major ongoing medical conditions; and secondly, people who have been diagnosed with Parkinson's disease, regardless of how long they've had the condition.

More specific health checks will be done by the study team to make sure it's safe for you to take part. This will involve reviewing your medical history and possibly having some tests.

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?
Are you generally healthy, or do you have Parkinson's disease?
Are you able to attend several clinic visits?
Are you comfortable taking a new, experimental medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, NT-0796. The exact number of visits and the total time you would be involved will depend on which group you are in (healthy volunteer or person with Parkinson's) and how the study is designed for your particular involvement.

Typically, early-stage studies like this involve several visits to a clinic or research unit. These visits may include physical examinations, blood tests, and sometimes other assessments to see how your body reacts to the medicine. You would be closely monitored by doctors and nurses to ensure your safety and to collect information about the medicine. The total duration of your participation could range from a few weeks to a few months, including any follow-up appointments.

Potential risks and benefits

Taking part in any research study has potential benefits and potential risks. A potential benefit of this study is helping advance medical science and potentially contributing to new treatments for Parkinson's disease in the future, even if you don't personally benefit from the medicine. Potential risks might include side effects from the new medicine, which could be mild (like a headache) or more serious, though every precaution is taken to ensure your safety. You would be carefully monitored for any side effects. Remember, 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
Netherlands

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain, causing problems with movement like shaking, stiffness, and difficulty with balance. It gets worse over time.

Why is this study being done if it's not looking at treatment yet?

This early study helps us understand how the new medicine works in the body and if it's safe. We need this information before we can test if it actually helps treat Parkinson's disease in larger studies.

Will I receive the new medicine?

Yes, if you join this study, you will receive doses of the experimental medicine called NT-0796.

What kind of tests will I have?

You can expect tests like physical exams, blood samples, and possibly others to check your health and how the medicine affects your body.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any point, and you don't need a reason. It won't affect any of your regular medical care.