Ongoing, recruitingHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study to learn how zilucoplan moves throughout the body over time when given in 2 different ways in healthy adults

This study is for healthy adults and is looking at how a new medicine, zilucoplan, works in the body. Researchers want to understand how the medicine travels through the body and how long it stays there when given in two different ways. This helps them figure out the best way to give the medicine in the future. It's an early-phase study, which means it's one of the first times this medicine is studied in people. The main goal is to compare the two ways of giving the medicine, to see if they deliver the same amount of medicine into the body. This kind of research is very important for developing new treatments safely and effectively.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

UCB Biopharma

Enrolment target

Start

12 Jun 2024

Healthy Volunteers

What is this study about?

Imagine your body is like a road network, and medicines need to travel along these roads to reach where they need to go. This study is like a mapping project for a new medicine called zilucoplan. In simple terms, researchers want to see how this medicine moves around your body and how long it stays there after you take it. They're particularly interested in comparing two different ways of giving the medicine to see if they end up delivering the same amount of medicine to your system.

This type of study is an early step in developing new medicines, often called a 'Phase I' study. It helps scientists understand basic information about how the medicine behaves in healthy people. This information is really important because it helps them decide how the medicine should be given in future studies for specific illnesses, ensuring it's both safe and effective.

By taking part, you would be helping researchers gather vital information that could one day lead to better treatments for various health conditions. It's a foundational study that paves the way for more advanced research.

Key takeaways

Study examines a new medicine called zilucoplan in healthy adults.
Investigates how the medicine moves through the body over time.
Compares two different ways of giving the medicine.
It's an early-stage study (Phase I) to gather basic safety information.
Participation helps future medical research develop new treatments.
Open to healthy adults aged 18 and over, both men and women.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should generally be well and not have any serious ongoing health conditions that would affect how the medicine works in your body.

You need to be at least 18 years old to join this study. There is no upper age limit, so adults of all ages, as long as they are healthy, can be considered.

Both men and women are welcome to participate in this research.

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 consider yourself generally healthy?
Do you have any serious ongoing health conditions?
Are you willing to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

The information provided doesn't give specific details about what taking part involves, such as the number of visits, assessments, or how the medication is given. However, in studies like this, participants typically undergo medical checks before starting to ensure they are healthy. You would likely receive the study medication (zilucoplan) in one of two ways being tested. Researchers would then take regular samples, such as blood or urine, over a set period to see how the medicine moves through your body and how long it stays there. There would also be follow-up appointments to check on your health. The total duration of your involvement isn't specified but would be explained in full by the research team.

Potential risks and benefits

Potential benefits for participants include receiving medical checks and contributing to important medical research that could help others in the future. As with any new medicine, there could be potential risks, such as side effects from zilucoplan, which may not be fully known at this early stage. The medical team will closely monitor your health throughout the study. 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 does 'bioequivalence' mean?

It means the study is comparing two ways of giving the same medicine to see if they deliver the same amount of medicine into your body at the same speed.

Will I get the actual medicine or a dummy pill?

Because this study is comparing two ways of giving the medicine, you will likely receive the active medicine, zilucoplan, through one of the two methods being tested.

What kind of health checks will I have?

Before you join, a doctor will check your general health to make sure you're suitable for the study. This usually involves a medical history, physical exam, and some blood tests.

How long will the study last for me?

The information available doesn't specify the exact duration. The research team will tell you precisely how long you would be involved.

Will I be paid for taking part?

Payment for participation varies between studies. You should ask the research team about any compensation or reimbursement for your time and travel.