Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A Phase 1/2a Study Evaluating the Effects of ARO-RAGE Inhalation Solution in Healthy Subjects and Patients with Inflammatory Lung Disease

This study, called a Phase 1/2a trial, is exploring a new inhaled medicine called ARO-RAGE. It's designed for people with long-term lung conditions where inflammation is a problem. The main goal is to find out if this new medicine is safe and well-tolerated by the body. Researchers will be carefully checking for any side effects in both healthy volunteers and patients. They will also be looking at how the medicine affects important measures of lung health, like how much air you can breathe out and how well your lungs take in oxygen. Some people will receive the new medicine, while others will receive a simple salt water spray for comparison.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Arrowhead Pharmaceuticals Inc.

Enrolment target

Start

05 Jul 2024

Inflammatory Lung Disease

What is this study about?

This study is being conducted to learn more about a new medicine called ARO-RAGE, which is given as an inhaled solution – meaning you breathe it in, similar to an asthma inhaler. The medicine is designed to help people who have inflammatory lung disease. This means their lungs are often irritated or swollen, which can make breathing difficult.

The study is split into two parts, Phase 1 and Phase 2. In Phase 1, researchers will give the medicine to healthy volunteers to understand how it behaves in the body and if it's safe at different doses. In Phase 2, they will give the medicine to people who actually have inflammatory lung disease. This will help them see if the medicine is not only safe but also has any positive effects on the lung condition.

The main thing the doctors want to find out is how safe ARO-RAGE is and if it causes any unwanted side effects when used over time. They will also measure how well participants' lungs are working by checking things like how much air they can breathe in and out, and how well their lungs can absorb oxygen. This will help them understand if ARO-RAGE could be a helpful treatment in the future.

Key takeaways

This study is testing a new inhaled medicine (ARO-RAGE) for safety and effect on lung disease.
It includes both healthy adults and people with inflammatory lung conditions.
The main goal is to check for side effects and how well the lungs work.
Participation involves regular clinic visits, lung tests, and possibly blood tests.
You might receive the new medicine or a salt water placebo.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.

There are two groups of people who might be able to take part. Some spots are for healthy adults without any current health problems, especially lung conditions. Other spots are for people who have been diagnosed with an inflammatory lung disease.

More specific details about your health, any other medicines you take, and previous medical history will be carefully checked by the study doctors to make sure the study is a good fit and safe for you.

Quick self-check

Are you 18 years old or older?
Do you have an inflammatory lung disease, or are you a healthy adult?
Are you able to attend regular clinic appointments?
Are you comfortable potentially receiving an unproven drug or a salt water placebo?
Are you willing to undergo various lung function 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 in this study, you might receive the experimental ARO-RAGE medicine or a salt water spray, both given as an inhalation solution. You will have regular visits to the study clinic where nurses and doctors will check your health and how you're feeling. They will ask about any new symptoms or side effects you might experience. You'll also have tests to measure your lung function, like breathing into a machine, and may have blood tests to see how the medicine is working in your body. The study will continue for a certain period, and you'll have follow-up appointments until the very end, known as End of Study (EOS).

Potential risks and benefits

Taking part in a study like this could potentially offer personal benefits, such as receiving a new treatment that might help your lung condition, or simply getting very careful medical attention and monitoring. However, there are also risks; the new medicine might cause side effects, some of which could be unexpected or unpleasant. The salt water spray is generally safe but might not provide any direct benefit for your condition. It’s important to remember that you can stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

—
Poland
—
Spain

Common questions

What is an 'inflammatory lung disease'?

It's a group of lung conditions where your lungs become irritated, swollen, and sometimes damaged, making it harder to breathe properly.

What does 'inhalation solution' mean?

It means the medicine is in a liquid form that you breathe in, usually through a special device, so it goes directly into your lungs.

What is a 'Phase 1/2a' study?

It's an early stage of research. Phase 1 mainly checks if a new medicine is safe. Phase 2a also looks at safety but starts to explore if the medicine might actually help treat the condition.

What are 'side effects'?

Side effects are any unwanted or unexpected reactions to a medicine, like headaches, nausea, or other symptoms.

Will I know if I'm getting the active medicine or the salt water?

Usually, in studies like this, neither you nor your doctor will know, to make sure the results are fair. This is called 'blinding'.