Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Cardiovascular safety assessment of Tanimilast in healthy volunteers

This research is an early study into a new medicine called Tanimilast. It’s given using an inhaler device called NEXThaler. The main goal is to carefully check how this new medicine affects the heart in healthy adult volunteers. Researchers will be monitoring heart rate and using heart tracings (ECGs) to look at electrical activity, including specific measurements like QT and QTc intervals, to make sure the medicine is safe for the heart. This is a Phase I study, which means it’s one of the first steps in testing a new medicine in people, focusing on safety and how the body handles it. It's an important step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Chiesi Farmaceutici S.p.A.

Enrolment target

Start

25 Jun 2025

What is this study about?

Imagine a new medicine that doctors hope will help people with certain health conditions. Before it can be given to patients who really need it, it has to go through several careful stages of testing to make sure it's safe and works well. This particular study is one of the very first stages, called a Phase I trial. It's like a very thorough safety check.

The main purpose of this study is to look closely at how a new medicine, called Tanimilast, affects a healthy person's heart. Tanimilast is given using a special inhaler device called NEXThaler. Researchers will be monitoring the volunteers' hearts very carefully. They will measure their heart rate and use a special test called an ECG (which records the electrical activity of the heart) to look at specific heart signals. This helps them understand if the medicine has any unwanted effects on the heart's rhythm or function.

Studying healthy volunteers at this early stage helps researchers understand the basic safety of a new medicine without the complexities of other health conditions. This information is absolutely vital because it helps decide if the medicine can safely move on to later stages of testing with people who have the condition it's designed to treat.

Key takeaways

This is an early-stage study (Phase I) of a new medicine called Tanimilast.
It's checking how the medicine affects the heart in healthy adult volunteers.
The medicine is given using an inhaler called NEXThaler.
Heart rate and electrical activity of the heart (ECGs) will be very closely monitored.
Participation helps vital medical research, but you can withdraw at any time.

Who may be eligible?

To join this study, you need to be a healthy adult who is at least 18 years old. There's no upper age limit, meaning older adults are welcome too, as long as they are healthy.

Both men and women can take part in this research. The study is specifically looking for healthy people because it helps the researchers see how the new medicine affects the body without other health problems getting in the way.

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 at least 18 years old?
Are you generally in good health?
Are you a man or a woman?
Do you understand this is a study for healthy individuals?

Answer every question to see your result.

What does participation involve?

The specific details of what’s involved aren’t fully available in the brief summary. However, typically, participating in a Phase I study like this would involve several visits to a clinic over a period of days or weeks. You would receive the study medicine, Tanimilast, via the NEXThaler inhaler. Throughout the study, medical staff would closely monitor your health, particularly your heart, using tools like ECGs and blood tests. You would likely need to stay at the clinic for certain periods after taking the medicine for observation. There may also be follow-up appointments after you've finished taking the study medicine to ensure everything is well. The total duration of your participation would be explained in full detail by the study team.

Potential risks and benefits

Participating in research always comes with potential risks and benefits. For this study, potential risks could include side effects from the investigational medicine, although specific side effects are not listed here. There might be discomfort from procedures like blood tests or ECGs. The potential benefit is contributing to medical science and helping to develop new treatments that could one day help many people. However, you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Bulgaria

Common questions

What is a Phase I study?

A Phase I study is one of the first steps in testing a new medicine in people. It mainly focuses on whether the medicine is safe and how the body handles it, usually in healthy volunteers.

What is Tanimilast?

Tanimilast is an investigational medicine, meaning it's still being tested. In this study, researchers are looking at its effects on the heart.

What does 'healthy volunteers' mean?

It means people who generally don't have any significant health problems that could affect how the medicine works or that could make the study unsafe for them.

Will I have to stay overnight?

The information doesn't say, but Phase I studies often involve overnight stays or long clinic visits for close monitoring after taking the medicine.

What is an ECG?

An ECG (electrocardiogram) is a simple, painless test that records the electrical activity of your heart to check its rhythm and function.