A Study to Evaluate the Effects of Various Degrees of Hepatic Impairment on the Pharmacokinetics of A Single Subcutaneous Dose Of RO7434656, an Antisense Inhibitor of Complement Factor B
This research study is focused on a new medicine called RO7434656, which is designed to block something in the body called 'complement factor B'. This medicine is given as a single injection under the skin. Researchers want to understand how a person's liver health affects how the body uses and gets rid of this medicine. They are specifically looking at people who have different levels of liver problems, from mild to more severe, as well as people with healthy livers. This is a very early study, called a Phase I study, which aims to gather basic information about the medicine's behaviour in the body rather than testing if it treats a specific illness.
At a glance
What is this study about?
This study is trying to understand more about a new medicine named RO7434656. Imagine your body is like a complex machine, and when you take medicine, different parts of the machine, like your liver, process it. This study wants to see how this particular medicine is handled by the body when someone has a liver problem, compared to someone with a healthy liver.
The medicine, RO7434656, is designed to block something called 'complement factor B' in your body. This 'complement system' is part of your immune system, which helps fight off infections, but sometimes it can cause problems if it's overactive. Learning how a new medicine works in people with different liver conditions is really important. It helps scientists figure out the right dose and how safe it is for people with varying health needs.
This is a very early stage 'Phase I' study. This means the main goal isn't to see if the medicine treats a specific disease yet. Instead, it's about gathering basic information like how long the medicine stays in the body, how quickly it's broken down, and how it's removed. This knowledge is crucial for developing the medicine further and ensuring it's used safely and effectively in the future.
Key takeaways
- This study investigates how a new medicine, RO7434656, behaves in people with different liver health.
- It's a very early-stage study (Phase I) focused on medicine safety and how the body handles it.
- Participation involves a single injection and regular health checks, including blood tests.
- The study aims to help scientists understand how liver problems might affect medicine doses.
- You must be 18 or older and can be male or female to take part.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
The main thing researchers are looking for is people with different levels of liver health. This includes people with completely healthy livers and those with mild to more significant liver problems.
There may be other health requirements too, which the study team will explain. This helps make sure the study is safe for everyone involved and that the results they get are clear and useful.
- Are you 18 years old or older?
- Are you a man or a woman?
- Do you have a healthy liver, or have you been diagnosed with some level of liver problem?
- Are you able to attend clinic visits as required by the study?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you will receive a single injection of the study medicine, RO7434656, under your skin. You'll have several visits to the study clinic before and after receiving the medicine. During these visits, the study team will likely take blood and urine samples to see how your body is handling the medicine. They will also do health checks to monitor your wellbeing.
The exact number of visits, tests, and the total time you'd be involved will be explained in detail by the study team. This information will be outlined in a document called an 'informed consent form' which you'll review before deciding to join.
Potential risks and benefits
Locations (3)
- —Slovakia
- —Germany
- —Poland
Common questions
What is 'hepatic impairment'?
Hepatic impairment simply means you have some degree of liver problem or liver damage.
What is a Phase I study?
It's the first step in testing a new medicine in people. It mainly checks how the medicine acts in the body and if it's safe, rather than if it treats a disease.
Will I get paid to participate?
This is something you would need to discuss directly with the study team. Some studies offer reimbursement for time and travel.
Is this medicine approved for use?
No, RO7434656 is an investigational medicine, meaning it's still being studied and is not yet approved for general use.
How is the medicine given?
The medicine is given as a single injection just under the skin, similar to some common vaccinations.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.