A Phase 2, Open-label, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability and Efficacy of ARCT-032 in People with Cystic Fibrosis
This research study is looking at a new medicine called ARCT-032 for adults with cystic fibrosis. It's an early-stage study (Phase 2), which means it's one of the first times this medicine is being tested in a larger group of people. The main goals are to find out if the medicine is safe, if people can take it without too many problems, and if it shows any signs of improving their condition. They will give different doses of the medicine to see how it affects participants. Researchers will check for any side effects, changes in general health, and how well the lungs are working, to understand if ARCT-032 could be a helpful treatment in the future.
At a glance
What is this study about?
This study is about a new medicine called ARCT-032 for adults living with cystic fibrosis. Cystic fibrosis is a condition that mainly affects the lungs, making it hard to breathe, and can affect other parts of the body too. The medicine ARCT-032 is still in the early stages of testing, which means doctors are carefully trying it out in a group of people to learn more about it.
The main aim of this study is to see if ARCT-032 is safe to use and if people with cystic fibrosis can take it without too many uncomfortable side effects. The researchers will also be looking for early signs that the medicine might be helping with the symptoms of cystic fibrosis, especially problems with breathing. They're giving different amounts of the medicine to participants to understand which dose might be best.
To figure this out, the study team will closely monitor participants for any side effects, big or small. They will also do regular health checks, like measuring blood pressure and taking blood tests. Importantly, they'll check how well the lungs are working before and after taking the medicine, paying close attention to breathing tests that measure lung function. This helps them understand whether ARCT-032 could be a promising new treatment option for cystic fibrosis in the future.
Key takeaways
- This study is testing a new medicine, ARCT-032, for adults with cystic fibrosis.
- The main goals are to check the medicine's safety and see if it helps improve health, especially breathing.
- It's an early-stage (Phase 2) study, meaning the medicine is still being carefully explored.
- Participants will receive different doses of the medicine and have regular health checks.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be an adult, aged 18 or older. The study is open to both men and women.
There will be other specific health requirements that aren't listed here. For example, you might need to have a certain level of lung function, or you might not be able to join if you have certain other medical conditions or are taking particular medicines.
The research team will carefully go through all the entry requirements with you to make sure the study is a safe and suitable option for you.
- Are you 18 years old or older?
- Do you have a diagnosis of cystic fibrosis?
- Are you able to attend regular appointments at the study site?
- Are you prepared to take a new investigational medicine?
- Are you comfortable having various medical tests including lung function tests and blood tests?
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'll be given the study medicine, ARCT-032, in different amounts over a period of time. It's an "open-label" study, which means both you and the study doctors will know you are receiving the active medicine.
Throughout the study, you'll have regular hospital visits. During these visits, the doctors and nurses will carry out several assessments. These will include general health checks like measuring your heart rate and blood pressure, taking blood and urine samples, and performing physical examinations. A key part of the study will involve lung function tests, where you'll be asked to breathe into a machine to measure how well your lungs are working.
The total length of time you'll be involved in the study, including how many visits you'll need, isn't specified here, but this is something the study team will explain in detail. You will be monitored closely for any side effects or changes in your health for the entire duration of your participation.
Potential risks and benefits
Locations (2)
- —Poland
- —Greece
Common questions
What is ARCT-032?
ARCT-032 is a new medicine being developed for people with cystic fibrosis. This study is testing its safety and effects.
What does 'Phase 2' mean?
Phase 2 means this is an early stage of testing. It's one of the first times the medicine is being given to a larger group of people to see if it's safe and if it shows any signs of working.
Will I know if I'm getting the real medicine?
Yes, this is an 'open-label' study, which means both you and the study team will know you are receiving the active ARCT-032 medicine.
What kind of tests will I have?
You'll have regular health checks, including blood tests, physical exams, and lung function tests to check your breathing ability.
How long will I be in the study?
The exact duration isn't mentioned here, but the study team will explain the full time commitment, including visits and follow-up, before you join.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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