Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A phase I study to evaluate an investigational medicinal product for the treatment of asthma, in healthy adult participants.

This study is an early-stage research project designed to test a new, unapproved medicine for asthma. It's called a 'Phase 1' study, which means it's the very first time this medicine will be given to people. The main goal is to see if it's safe and how it behaves in the human body, not yet to treat asthma itself. Researchers will be looking at things like how much of the medicine stays in the body and for how long. Only healthy adults aged 18 and over, both men and women, can take part. This important step helps scientists understand if the new medicine has the potential to become a treatment for asthma in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Chiesi Farmaceutici S.p.A.

Enrolment target

Start

19 Jul 2023

Asthma

What is this study about?

This study is a very early stage of medical research focused on a new medicine that could one day help people with asthma. It's often called a 'Phase 1' study. At this stage, the medicine hasn't been given to people before, so the main aim is to carefully check its safety and how it works inside the body.

Researchers will be giving this new medicine to healthy adult volunteers. This is important because it allows them to see the effects of the medicine in people who are otherwise well, helping them understand how the medicine is absorbed, distributed, processed, and removed by the body. They'll also be looking closely for any side effects.

Finding new and better ways to treat asthma is really important, as it affects many people. This study is a crucial first step in that journey. If the medicine proves to be safe in this phase, it can then move on to later stages of research where it will be tested in people who actually have asthma, to see if it helps their condition.

Key takeaways

Tests a new asthma medicine for the first time in humans.
Focuses on safety and how the medicine works in the body.
Only for healthy adults, aged 18 and over.
An early but important step in developing new treatments.
Participation involves medical checks and possibly clinic visits.

Who may be eligible?

This study is looking for healthy adults. You must be at least 18 years old to take part; there is no upper age limit mentioned.

Both men and women are welcome to volunteer for this research. The study needs people who are generally well and do not have current health problems that might affect how the new medicine works or put them at extra risk.

More detailed checks will be done by the study team to make sure it's safe for you to participate. This might include a medical check-up, blood tests, and reviewing your health history.

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?
Are you generally healthy?
Are you willing to potentially have multiple clinic visits or stays?
Are you comfortable with taking an investigational new medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the investigational medicine. The study team would explain exactly how and when you would take it. This early phase study usually involves several visits to a clinic or hospital, and often includes overnight stays, especially at the beginning.

During your participation, you would have regular medical checks, including blood tests, urine tests, and monitoring of your vital signs (like blood pressure and heart rate). These tests help the researchers understand how your body is reacting to the medicine and to monitor for any side effects.

The total length of your participation would be explained to you before you agree to join, but Phase 1 studies can vary, often lasting from a few weeks to a couple of months depending on the medicine being tested and the number of doses given. There will also be follow-up checks after you stop taking the medicine.

Potential risks and benefits

Participating in research can have potential benefits, such as contributing to medical science and helping to find new treatments for asthma. For this study, as a healthy volunteer, you wouldn't directly benefit from treating asthma, as that's not the goal at this stage. However, you will receive close medical attention and health checks. There are always potential risks with taking any new medicine, including unknown side effects. The research team will carefully monitor you for any problems. You will be given full information about known risks, and you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

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

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Unverified
Belgium

Common questions

What does 'Phase 1' mean?

Phase 1 means this is the very first time a new medicine is being tested in people. The main goals are to check if it's safe and how it works in the body.

Will this medicine cure my asthma?

No, this study is not designed to treat asthma. It's looking at safety and how the medicine works in healthy adults first, before it's tested in people with asthma.

Who can take part in this study?

This study is looking for healthy adults aged 18 or over. Both men and women can participate.

Will I have to stay in a clinic?

Some Phase 1 studies require overnight stays, especially in the beginning, so that researchers can closely monitor you after you receive the medicine.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.