Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Selnoflast in Participants with Moderate to Severe Asthma

This research is looking into a new medicine called Selnoflast, designed for individuals living with moderate to severe asthma. The main goals are to understand if the medicine is safe to use, how the body handles it, and what effects it has on the body. This is an early phase of testing in humans, often called a Phase I study. This means it's one of the first times this medicine is being given to people. The study is open to adults, aged 18 and older, of any gender. While a detailed description isn't available yet, the overall aim is to gather important initial information about this potential new asthma treatment.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

22 Jan 2024

Moderate to Severe Asthma

What is this study about?

This study is investigating a new medication called Selnoflast, which is being developed for people who have moderate to severe asthma. If you have moderate to severe asthma, it means your symptoms can be quite troublesome and might significantly impact your daily life.

The main purpose of this research is to learn more about Selnoflast. The doctors and scientists want to find out if it's safe for people to take and if it causes any unwanted side effects. They also want to understand how the medicine travels through your body and how your body processes it. This is important for figuring out the right dose to use in the future.

This is an early-stage study, often called a 'Phase I' study. Think of it as the first step in testing a new medicine in people. At this stage, the focus is heavily on safety and understanding the basics of how the medicine works in the human body, rather than on whether it cures the condition. The information gathered from this study will help decide if Selnoflast should be studied further in larger groups of people.

Key takeaways

This study is for a new medicine called Selnoflast for moderate to severe asthma.
It's an early-stage study to check for safety and how the medicine works in the body.
Only adults aged 18 and over can join.
Participation involves taking the study medicine and having regular health checks.
You have the right to leave the study at any time without affecting your normal care.

Who may be eligible?

This study is looking for volunteers who are aged 18 years or older. There is no upper age limit mentioned.

It is open to both men and women. Generally, studies like this look for people who specifically have moderate to severe asthma.

While the main requirements are being an adult with moderate to severe asthma, there will be other specific health checks to make sure the study is safe for you and that the results will be clear. For example, doctors will likely check your other current health conditions and any medications you are taking.

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 moderate to severe asthma?
Are you able to attend regular clinic visits?
Are you open to trying a new, experimental medicine?
Are you willing to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, Selnoflast, as part of the study. You would have several scheduled visits to the study clinic or hospital. These visits would involve various health checks, such as blood tests, physical examinations, and possibly tests to measure your asthma symptoms and lung function. The exact number and length of these visits, as well as the total duration of your participation, would be explained in detail by the study team. There would also be a follow-up period to monitor your health after you stop taking the study medicine.

Potential risks and benefits

Participating in any study has potential benefits and risks. A potential benefit of taking part is that you would receive close medical attention and access to a new experimental medicine for your asthma that is not yet available to the general public. However, there is no guarantee that Selnoflast will improve your asthma, and like all medicines, it might cause side effects, some of which could be unexpected or unpleasant. You would be fully informed of all known risks before deciding, and importantly, you are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Belgium
—
Unverified
Netherlands
—
Unverified
Germany

Common questions

What kind of asthma is this study for?

This study is for people who have moderate to severe asthma.

How old do I need to be to join?

You need to be 18 years old or older to take part in this study.

Is this medicine already available?

No, Selnoflast is a new medicine being tested and is not yet available to the public.

Will this medicine cure my asthma?

This early study aims to check safety and how the medicine works, not to cure asthma. There's no guarantee it will improve your condition at this stage.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time, without giving a reason, and it won't affect your regular medical care.