A Phase 1b/2 Single and Multiple Dose Study to Assess the Safety, Tolerability, Clinical Activity, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of STAR-0215 in Participants with Hereditary Angioedema (The ALPHA-STAR Trial)
This research study, called ALPHA-STAR, is looking into a new experimental medicine named STAR-0215 for people who have Hereditary Angioedema (HAE). HAE causes sudden, unpredictable swelling attacks. The main aim of this study is to carefully check if STAR-0215 is safe to use and how well people tolerate it. We'll also be watching to see if it helps reduce the number and severity of HAE attacks. Researchers will give different doses of the medicine to see how it works in the body and if it causes any unwanted side effects. This is an early phase of testing (Phase 1b/2), which means it's one of the first times this medicine is being given to people with HAE to learn more about it before it can be widely used.
At a glance
What is this study about?
Hereditary Angioedema, or HAE, is a rare condition that causes sudden and painful swelling in different parts of the body, like the hands, feet, face, or airways. These swelling attacks can be very uncomfortable and even dangerous if they affect the throat. The ALPHA-STAR study is looking at a new potential medicine, STAR-0215, which is hoped to help prevent or reduce these attacks. This is an exciting step because finding new treatments can make a big difference to people living with HAE.
In this study, researchers want to answer several important questions. Firstly, they need to make sure STAR-0215 is safe. They will closely monitor participants for any side effects or changes in their health. Secondly, they want to understand how the medicine works in the body – how much is absorbed, how long it stays there, and how it affects the processes involved in HAE attacks. They will also look at whether the medicine helps reduce the number, severity, and duration of HAE attacks that people experience.
This study combines two early phases of research (Phase 1b and Phase 2), which means it's an important step in developing new medicines. It's designed to gather a lot of information about STAR-0215 in people with HAE. The results from this study will help decide if STAR-0215 is promising enough to be tested in larger studies in the future, with the ultimate goal of offering a new treatment option for HAE.
Key takeaways
- This study explores a new medicine (STAR-0215) for Hereditary Angioedema (HAE).
- Its main goals are to check the medicine's safety and how it works in the body.
- Researchers will also see if it helps reduce HAE attacks.
- It's an early-stage study, paving the way for potential future treatments.
- Only adults aged 18 and over with HAE can participate.
Who may be eligible?
To join this study, you need to be an adult, at least 18 years old. Both men and women can take part. The study is specifically for people who have been diagnosed with Hereditary Angioedema (HAE).
There might be other specific health requirements or conditions that could mean you can't join. For example, certain other medical conditions or medicines you are taking might prevent you from participating in order to ensure your safety and the accuracy of the study results.
If you're interested, the best thing to do is talk to your doctor. They can help you understand all the requirements and decide if this study might be a good fit for you.
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 have a diagnosis of Hereditary Angioedema (HAE)?
- Are you able to attend regular clinic visits?
- Have you discussed this with your regular doctor?
What does participation involve?
If you decide to join the ALPHA-STAR study, you will receive the investigational medicine, STAR-0215, as directed by the study doctors. This medicine is still being researched, and its effects are not fully known. You will have regular visits to the clinic, where the study team will closely monitor your health. This will involve physical examinations, checking your vital signs (like blood pressure and heart rate), taking blood and urine samples, and performing ECGs (heart tests).
You will also be asked to keep a record of any HAE attacks you experience, including how severe they are and how long they last. The study will look at how your HAE symptoms change over time while taking the medicine. The total duration of your participation in the study will be discussed with you by the research team.
Potential risks and benefits
Locations (4)
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedGermany
Common questions
What is Hereditary Angioedema (HAE)?
HAE is a rare genetic condition that causes sudden and unpredictable swelling attacks in various parts of the body.
What is STAR-0215?
STAR-0215 is a new medicine being tested in this study to see if it can help people with HAE.
Is this medicine available to everyone?
No, STAR-0215 is an investigational medicine, which means it's only available to people participating in this clinical trial right now.
What does 'Phase 1b/2' mean?
It means this is an early stage of research. Phase 1b checks safety and how the body handles the medicine, and Phase 2 looks at how well it works.
Will I know if the medicine is working for me?
The study team will closely monitor your HAE attacks and other health information, and you'll have regular discussions about how you're feeling.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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