RIG 101 Trial in Healthy Adults and Adults With Asthma
This research study is looking at a new medicine called RIG-101. It's designed to see if RIG-101 is safe for adults, and if it can help prevent or ease asthma attacks, especially those caused by colds or other respiratory infections. We're inviting both healthy adults and adults who have asthma to take part. The study is split into two main parts. First, we'll check how safe the medicine is at different doses. Then, we'll see how well it works, particularly when people are exposed to a virus that often causes colds. This information will help us understand if RIG-101 could be a helpful new treatment option for people with asthma in the future.
At a glance
What is this study about?
This study, called the RIG 101 Trial, is looking into a new medicine called RIG-101. The main goal is to find out if this medicine is safe for people to take and if it can help those with asthma, especially if their asthma gets worse during a cold or respiratory infection. Researchers are testing this medicine in both healthy people and people who have asthma to get a full picture of its effects.
The study is happening in two stages. The first stage focuses on safety: researchers will give RIG-101 to a small group of healthy people and carefully watch for any side effects. Once they understand the safe dose, the study will move to the second stage. In this part, they will also include people with asthma and see if RIG-101 helps them stay healthy or reduces their asthma symptoms, especially if they are exposed to a common cold virus as part of the study.
Understanding how new medicines like RIG-101 work and whether they are safe and effective is a really important step in developing new treatments. This study aims to gather crucial information that could lead to better ways to manage asthma, particularly for people whose asthma is triggered by infections.
Key takeaways
- This study is testing a new asthma medicine called RIG-101.
- It's for healthy adults and adults with asthma, aged 18-65.
- The study explores the medicine's safety and how well it works, especially against cold-triggered asthma.
- Participants will receive either RIG-101 or a placebo.
- Some participants might be given a cold virus to test the medicine's effectiveness.
- Participation is voluntary, and you can withdraw at any point.
Who may be eligible?
To join this study, you need to be an adult between 18 and 65 years old. Before you can take part, you'll have a health check-up, including a review of your medical history, a physical exam, and some basic tests like blood tests and an ECG (a heart tracing). This is to make sure you're generally in good health and that taking part in the study would be safe for you.
If you have asthma, there are a few extra things the researchers will check. For example, they'll need to confirm your asthma diagnosis, maybe do some breathing tests (like FEV1), and check if you've had asthma flare-ups recently due to colds. They'll also look at your current asthma medicines to make sure you fit the study's requirements. If you don't have asthma, you'll still need to meet some breathing test requirements to show your lungs are healthy.
There are also reasons you might not be able to join. For instance, if you have other serious health problems, either long-term or short-term, that could affect your safety in the study, you wouldn't be able to participate. The medical team will carefully review all your health information to make sure joining the study is right 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 between 18 and 65 years old?
- Are you generally in good health, or do you have a stable asthma diagnosis?
- Do you have a history of asthma worsening with colds/infections (if you have asthma)?
- Are you able to attend regular clinic visits and follow study instructions?
- Do you not have any other serious health conditions that might make participating unsafe?
What does participation involve?
If you decide to take part, you'll be given either the new medicine, RIG-101, or a placebo (a dummy medicine that looks like RIG-101 but has no active ingredients). This is decided randomly, like flipping a coin, so neither you nor the study team knows whether you're getting the active drug or the placebo during the study. You will have regular visits to the clinic for check-ups, which include physical exams, blood tests, and breathing tests. You might also be asked to keep a diary of your symptoms.
For some participants, particularly in the later stage of the study, there might be a 'viral challenge'. This means you would be given a cold virus in a controlled way to see how the medicine helps your body cope with it and how it affects your asthma. The study will involve several visits over a period of time, and the total length will depend on which part of the study you are in. All procedures and the full timeline will be clearly explained before you agree to participate.
Potential risks and benefits
Locations (2)
- Virtus Respiratory Research LtdVerified postcodeLondon, United Kingdom· Not yet recruiting
- Medicines Evaluation UnitVerified postcodeManchester, United Kingdom· Recruiting
Common questions
What is RIG-101?
RIG-101 is a new medicine being tested to see if it's safe and if it can help people with asthma, especially when their asthma is triggered by colds.
What is a 'placebo'?
A placebo is a dummy medicine that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine.
Will I know if I'm getting the medicine or the placebo?
No, during the study, neither you nor the study team will know if you're receiving RIG-101 or the placebo. This helps ensure the results are unbiased.
What does 'viral challenge' mean?
A central part of this study involves giving participants a common cold virus in a controlled way. This allows researchers to see how effective the new medicine is at controlling asthma symptoms during an infection.
Can I leave the study at any time?
Yes, you are free to leave the study at any time, for any reason, and it will not affect your routine medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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