RecruitingPHASE1INTERVENTIONAL

Evaluation of Safety, Side Effects, and How the Drug, Inhaled CHF10136, Is Absorbed, Modified and Removed From the Body in Healthy Adults and Adults With Asthma

This research is looking at a new inhaled medicine called CHF10136, which could potentially help people with asthma. It's the very first time this medicine is being given to humans, so the main goal is to check its safety and how well people can tolerate it. Scientists also want to understand how the medicine moves through the body, how it changes, and how it's removed. The study involves both healthy volunteers and people who have asthma. They will receive different amounts of the medicine, or a dummy treatment, over various periods. This early stage of testing is crucial for finding out if the medicine is safe enough to explore further as a possible asthma treatment.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Chiesi Farmaceutici S.p.A.

Enrolment target

120

Start

02 Oct 2026

Estimated completion

27 Dec 2027

Asthma Healthy Volunteers

What is this study about?

Imagine a new medicine that could help people with asthma breathe more easily. Before it can ever be given widely, it needs to go through careful testing. This study is one of the very first steps in that process for a new inhaled medicine called CHF10136. Think of it like a brand new car being tested on a track before it's allowed on public roads. The main aim is to make sure it's safe and doesn't cause too many problems. Researchers are also keen to learn how the body deals with this medicine – how much gets into the blood, how long it stays there, and how the body gets rid of it. This helps them understand the best way to give it in the future.

The study involves different groups of people. Firstly, healthy adults will take the medicine to see how it affects someone without asthma. Then, people with mild asthma, and later those with more moderate to severe asthma, will also take part. This helps researchers understand if the medicine behaves differently in people with the condition it's designed to treat. Some people will get the active medicine, while others will get a placebo – which looks exactly like the medicine but contains no active ingredient. This is a standard way to ensure the results are fair and accurate.

This is a 'Phase 1' study, meaning it's an early-stage trial focused primarily on safety and understanding the medicine's basic behaviour in the human body. It's a vital step towards developing new treatments, but it's important to remember that it doesn't aim to cure asthma or provide direct medical benefit to participants at this stage. It's about gathering important information to guide future research.

Key takeaways

This is an early study of a new inhaled medicine (CHF10136) for asthma.
The main focus is on safety and how the body handles the medicine.
It involves both healthy adults and adults with asthma.
You might receive the active medicine or a placebo (dummy medicine).
Participation involves regular health checks and drug administration.
The aim is to gather important information for future asthma treatments, not to treat your asthma directly.

Who may be eligible?

To join this study, you generally need to be an adult between 18 and 65 years old. Your weight should be within a certain range for your height (your Body Mass Index or BMI). You also need to be in good overall health, as checked by doctors and nurses.

For some parts of the study, healthy adults are needed. For other parts, people with asthma are needed. If you have asthma, it needs to have been diagnosed for at least six months and before you were 50. You might also need to have certain lung function test results and not be taking certain asthma medicines right before the study.

It's also important that you are willing and able to follow all the study's instructions, which will be explained clearly to you. The study team will review your medical history and perform health checks to confirm if you are suitable.

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?
Is your weight within a healthy range for your height?
Are you in good general health, or do you have asthma that meets certain criteria?
Are you able and willing to attend study visits and follow instructions?
If you have asthma, was it diagnosed before age 50 and at least 6 months ago?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the new inhaled medicine (CHF10136) or a dummy medicine (placebo) using a dry powder inhaler. This will happen over different periods, sometimes as a single dose, sometimes multiple doses over a short time, and for some, repeated doses over a longer period.

You'll have regular visits to the clinic for various checks. These will include: blood tests to see how your body handles the medicine, urine tests, lung function tests (like breathing into a machine), and checks of your general health, such as blood pressure and heart rate. The study team will closely monitor you for any side effects or changes in your health.

The total duration of your participation will depend on which part of the study you join, but it will involve attending clinic visits and following instructions for medication use and safety monitoring. All details will be fully explained before you agree to take part.

Potential risks and benefits

Taking part in a research study like this may not offer direct personal health benefits. However, the information gathered could help in developing new and improved treatments for asthma in the future, benefiting others. There are potential risks, as with any new medicine, including possible side effects that are not yet fully known. The study team will carefully monitor your health for any issues. You have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (3)

Fortrea Leeds CRU
Verified postcode
Leeds, United Kingdom· Recruiting
hVIVO
Verified postcode
London, United Kingdom· Not yet recruiting
MEU
Verified postcode
Manchester, United Kingdom· Not yet recruiting

Common questions

What is CHF10136?

CHF10136 is a new inhaled medicine being tested to see if it could help people with asthma. This study is the first time it's being given to humans.

Who is eligible to join this study?

Adults aged 18 to 65, including healthy volunteers and people with asthma, may be eligible. Specific health and lung function criteria apply, which the study team will check.

Will I definitely get the new medicine?

No, some participants will receive the active medicine, while others will receive a 'placebo' – a dummy inhaler that looks the same but contains no active drug. This is a common practice in research.

What kind of tests will I have if I join?

You'll have regular health checks, including blood and urine tests, lung function tests (like blowing into a machine), and monitoring of your heart rate and blood pressure.

What's the main goal of this study?

The main goal is to find out if the new medicine (CHF10136) is safe and how the human body handles it, helping researchers decide if it's worth exploring further for asthma treatment.

How to find out more

Chiesi Clinical trial Info clinicaltrials_info@chiesi.com

clinicaltrials_info@chiesi.com +390521279715 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.