RecruitingEARLY_PHASE1INTERVENTIONAL

Phase I Study to Evaluate KP405 in Healthy and Parkinson's Disease Patients

This early-stage study is testing a new medicine called KP405. It's designed to see if KP405 is safe for people to take, both those who are healthy and those with Parkinson's disease. We also want to understand how the body uses and gets rid of the medicine, and what effects it might have. This is a very initial study, meaning it's one of the first times this medicine is being given to people. The main goal is to check for any safety concerns and how well people can tolerate the medicine. This information is crucial for deciding if further research into KP405 as a potential treatment for Parkinson's disease should continue.

At a glance

Status

Recruiting

Phase

EARLY_PHASE1

Sponsor

Kariya Pharmaceuticals

Enrolment target

Start

01 Aug 2024

Estimated completion

31 Mar 2026

Safety Issues Tolerance

What is this study about?

This study is about a new medicine called KP405, which scientists are hoping might one day help people with Parkinson's disease. Because it's a new medicine, the very first and most important thing we need to do is make sure it's safe. That's why this is called an 'early phase 1' study.

In this study, doctors will give KP405 to a small group of people. Some will be healthy volunteers, and others will be people who have Parkinson's disease. By doing this, we can carefully watch for any side effects or problems. We'll also be looking at how the body deals with KP405 – how much gets into the blood, how long it stays there, and how it leaves the body. This helps us understand the right amount of medicine to give.

Another important part of this study is checking for any early signs of how KP405 affects the body. While it's too soon to expect big improvements in Parkinson's symptoms at this early stage, observing these effects gives us clues about whether KP405 is working the way scientists hope. All this information helps researchers decide if KP405 is promising enough to continue testing in larger studies, with the ultimate goal of developing a new treatment for Parkinson's.

Key takeaways

This is an early-stage study testing a new medicine for Parkinson's.
The main goals are to check for safety and how the body handles the medicine.
It involves healthy volunteers and people with Parkinson's disease.
You might receive the new medicine or a dummy pill.
You'll have regular medical checks and tests throughout the study.

Who may be eligible?

To join this study, you would need to be between 18 and 80 years old. If you're a healthy volunteer, a doctor would check your health thoroughly to make sure you're well. This would involve looking at your medical history, doing a physical check-up, checking your blood pressure, and possibly an ECG (heart test) and regular blood tests.

If you have Parkinson's disease, you would need to have a clear diagnosis of Parkinson's that meets specific medical guidelines. The study doctors also need to make sure you don't have any other significant health problems apart from Parkinson's that could interfere with the study. For example, if you've had a stroke or mini-stroke in the last year, or recent severe head injury, you likely wouldn't be able to join.

It's very important that a study doctor reviews your full medical history. They will check for any other serious medical conditions (like heart, lung, kidney, or liver problems) or mental health issues that could make it unsafe for you to take part. This careful checking process is to ensure your safety throughout 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.

Are you between 18 and 80 years old?
Are you generally healthy, or do you have a confirmed diagnosis of Parkinson's disease?
Do you have any other serious medical conditions (like heart, kidney, or liver problems)?
Have you had a stroke, mini-stroke, or severe head injury recently?
Are you able to attend several clinic visits for checks and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new medicine, KP405, or a placebo (a dummy medicine that looks like KP405 but contains no active drug). You wouldn't know which one you are taking. There will be several visits to the study clinic, where doctors and nurses will monitor your health very closely. They'll perform various tests, including physical examinations, blood tests, and possibly heart scans or other checks to see how you are responding to the medicine and if you have any side effects.

These visits might involve spending some time at the clinic, and some may require an overnight stay. You would be given instructions on how to take the medicine, and when to report any changes in your health. The total length of your participation, including all visits and follow-ups, would be explained to you before you agree to join. You would be asked to follow specific rules regarding other medicines you take and possibly your diet or activities.

Potential risks and benefits

Because this is an early study, the main benefit is helping scientists learn more about KP405 and potentially pave the way for a new Parkinson's treatment in the future. You might not personally feel better or see a direct benefit from this medicine right now. However, you would be closely monitored by medical professionals, and you would receive the new medicine or placebo at no cost. Like all medicines, KP405 could have side effects, which might be mild or, in rare cases, more serious. All potential risks will be explained in detail before you decide to join. You are always free 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.

MAC
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is a 'Phase 1' study?

It's the first time a new medicine is tested in people. The main aim is to check if it's safe and to understand how the body handles it.

Will I get the actual medicine or a dummy pill?

You might get either the new medicine (KP405) or a placebo (a dummy pill with no active ingredient). You won't know which one you're taking.

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain, causing problems with movement like tremor, stiffness, and difficulty with balance and walking.

Will this medicine cure my Parkinson's?

This is an early study focused on safety, not a cure. There is no guarantee you will see an improvement in your symptoms.

What happens if I want to stop taking part?

You can leave the study at any time, for any reason. Your decision will not affect your regular medical care.

How to find out more

Ian Laquian, MBA

ian.laquian@kariyapharma.com 5170029 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.