Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A randomised, double-blind, placebo-controlled trial to assess the effects of EP395 following an inhaled endotoxin challenge in healthy adults

This research is looking at a new medicine called EP395. The study involves healthy adult volunteers and aims to see how EP395 affects their lungs after a mild irritation. This irritation is caused by inhaling a very small, safe amount of a substance found in bacteria, which mimics some of the inflammation seen in lung conditions like COPD. The researchers want to learn if EP395 can help protect the lungs or reduce this irritation. This is a very early study (Phase 1), focusing on whether the medicine is safe and how it works in the body, rather than treating a specific illness. Participants will be given either EP395 or a dummy medicine (placebo) without knowing which one they receive.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

EpiEndo Pharmaceuticals ehf.

Enrolment target

Start

15 Nov 2024

Healthy volunteers [targeted indication: chronic obstructive pulmonary disease (COPD)]

What is this study about?

This study is an early research project (what scientists call 'Phase 1'). This means it's one of the first times this new medicine, EP395, is being tested in humans. The main goal is to understand how EP395 works in the body and if it's safe. It's not about treating a specific disease yet, but rather gathering important information that could help people with certain lung conditions in the future.

The researchers are particularly interested in how EP395 might affect the lungs. To do this, they will give healthy volunteers a very tiny, controlled amount of a substance that can cause a temporary, mild irritation in the airways. This irritation is carefully managed and is similar to some of the inflammation seen in conditions like Chronic Obstructive Pulmonary Disease (COPD), though participants in this study are healthy and don't have COPD themselves. By observing how EP395 interacts with this mild irritation, the scientists hope to learn if the medicine could potentially protect the lungs or help reduce inflammation.

This type of study is really important because it lays the groundwork for developing new treatments. If EP395 shows promise in protecting the lungs in this early stage, it could one day lead to better ways to help people living with conditions like COPD. The study is carefully designed to be as safe as possible, and healthy volunteers are crucial for helping us understand these new medicines.

Key takeaways

This is an early study (Phase 1) of a new medicine called EP395.
It involves healthy adult volunteers, aged 18 and over.
The aim is to see how EP395 works in the lungs after a mild, safe irritation.
It helps researchers understand if EP395 could protect lungs from inflammation.
You might receive the new medicine or a dummy medicine (placebo).
Participation contributes to future treatments for lung conditions.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or over. This study is looking for healthy people to help understand how a new medicine works, rather than trying to treat an illness.

Because this is an early study, there will be strict rules about who can take part to make sure it's as safe as possible for everyone involved. For example, you wouldn't be able to join if you have any serious ongoing health problems, if you are pregnant or breastfeeding, or if you are taking certain medications that might interfere with the study medicine.

The research team will carry out several health checks to make sure you are a good fit for the study and that it would be safe for you to take part. They will explain all the requirements in detail.

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.

Am I a healthy adult?
Am I 18 years old or older?
Do I have any serious ongoing medical conditions?
Am I currently pregnant or breastfeeding?
Am I taking any regular medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a screening visit to check if you are suitable. This would involve health checks, blood tests, and a review of your medical history. If eligible, you would then attend several study visits over a period. During these visits, you would receive either the new medicine, EP395, or a dummy medicine (placebo) through an inhaler. You won't know which one you're getting. You would also have a small, safe amount of an irritant inhaled into your lungs. Researchers would then monitor your lung function and take blood samples to see how your body responds. You would be carefully monitored throughout the study. The total duration of your participation, including all visits and follow-up, would be fully explained by the study team.

Potential risks and benefits

The potential benefit of taking part is contributing to medical research that could one day help people with lung conditions like COPD. You would also receive expert medical care and monitoring throughout the study. Potential risks could include mild side effects from the study medicine or the inhaled irritant, such as temporary coughing or shortness of breath, or discomfort from blood tests. As with any medicine, there's a chance of unexpected reactions, but the research team will monitor you closely. 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.

—
Unverified
Germany

Common questions

What is EP395?

EP395 is a new medicine being tested. This study is one of the first times it's being given to healthy people to see how it works and if it's safe.

Why are you calling this a 'dummy medicine'?

A 'dummy medicine' is also called a placebo. It looks exactly like the real medicine but contains no active drug. This helps researchers compare the effects of the new medicine fairly.

What is an 'inhaled endotoxin challenge'?

It means you will breathe in a very tiny, safe amount of a substance that can cause a temporary, mild irritation in your lungs. This helps researchers understand how your lungs respond and if the new medicine helps.

Will I get 'COPD' from this study?

No, absolutely not. You will be a healthy volunteer, and the mild irritation is temporary and carefully controlled. It is used to understand lung responses, not to cause an illness.

Do I have to pay to join?

No, you do not have to pay. All study-related care and medicines are provided free of charge. You may also receive some money for your time and travel.