Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Phase Ib Safety, Tolerability and Pharmacokinetic Study of Subcutaneously Administered HER-096 in Healthy Volunteer Subjects and Patients with Parkinson’s Disease

This is a very early study, called a Phase 1b trial, for a new medicine named HER-096. It's designed to see if the medicine is safe when given as an injection under the skin and how the body processes it. The study involves both healthy people and individuals who have Parkinson's disease. Finding out this information is a crucial first step in developing new treatments. Understanding the medicine's safety and effects in humans helps scientists decide if it's worth continuing to test it in larger studies. The ultimate goal is to find new ways to help people living with Parkinson's disease, and studies like this are important stepping stones in that journey.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Herantis Pharma Oyj

Enrolment target

Start

03 Sep 2024

Parkinson’s Disease

What is this study about?

This study is a very early step in checking a new medicine called HER-096. It's for people with Parkinson's disease, but it will also involve some healthy volunteers. The main aim is to see if this new medicine is safe to use and how the body handles it after it's injected under the skin. Think of it like a first test drive for a new car – you want to make sure it's safe to be on the road before you let a lot of people drive it. This stage of research is called 'Phase 1b'.

The researchers are particularly interested in something called 'pharmacokinetics'. This is a scientific way of saying they want to understand what the body does to the medicine – how it's absorbed, distributed, broken down, and removed. Knowing this helps them figure out the best dose and how often the medicine should be given to have the best chance of working safely.

While this study won't tell us if HER-096 can fully treat Parkinson's, it's essential for figuring out if it's safe enough to move to bigger studies that *will* look at its effects on the disease. Every new medicine that helps people starts with early safety studies like this one.

Key takeaways

This is an early-stage study for a new Parkinson's medicine, HER-096.
The main goals are to check the medicine's safety and how the body processes it.
It involves both healthy volunteers and people with Parkinson's disease.
Participation includes receiving injections and regular health check-ups.
You won't necessarily receive direct benefits, but you help advance medical research.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 years or older. Both men and women can take part. Researchers are looking for two main groups of people: healthy volunteers who don't have Parkinson's, and people who have been diagnosed with Parkinson's disease.

There will be specific health checks and tests to make sure that taking part in the study is safe for you. These checks are important because the researchers want to make sure that any health conditions you have wouldn't make the new medicine risky for you. They will also need to make sure that the results of the study are clear and reliable.

Before you can join, a study doctor will carefully review your medical history and current health to see if this study is a good fit for you. It's important to remember that not everyone who is interested will be able to join, as studies have very strict rules to protect participants and ensure good results.

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 (or don't you) have a diagnosis of Parkinson's disease, depending on what group they're recruiting for?
Are you able to attend appointments regularly?
Are you willing to receive injections and have blood tests?
Are you generally in good health, or do you meet specific health requirements if you have Parkinson's?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, HER-096, as an injection under your skin. The study team will explain exactly how and where this injection will be given. You would need to attend several visits to the clinic or hospital. During these visits, the study team would closely monitor your health, take blood samples, and perform various tests to see how your body is reacting to the medicine.

There will be regular check-ups to make sure you are feeling well and to record any changes or side effects you might experience. These visits will help the researchers understand the medicine's safety and how it's being handled by your body. The total length of your participation, including all visits and follow-up, would be made clear to you before you agree to join.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For this early-stage study, the main benefit is helping researchers learn more about a potential new medicine for Parkinson's, which could help future patients. You might not directly benefit from taking the medicine yourself. Potential risks could include side effects from the medicine, discomfort from injections or blood tests, or unforeseen reactions. The research team will explain all known risks to you. You are free to ask questions at any time and can decide to stop participating in the study at any point without giving a reason, and your medical care will not be affected.

Locations (1)

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

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Unverified
Finland

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition where parts of the brain become progressively damaged over many years, leading to symptoms like shaking, slow movement, and stiffness.

What does 'Phase 1b' mean?

It's an early stage in medicine testing where researchers check a new medicine's safety, side effects, and how the body handles it in a small group of people, including some with the condition being studied.

Will this medicine cure Parkinson's?

This early study is about safety, not finding a cure. While we hope for future treatments, this study is a first step to see if the medicine is safe enough to test further.

Do I have to pay to join the study?

No, you don't pay to join. Study-related care, tests, and the investigational medicine are typically provided at no cost, and sometimes travel expenses are reimbursed.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your medical care.