Not yet recruitingPHASE1INTERVENTIONAL

Phase 1 PK Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients

This early-stage study is testing a new inhaled medicine called AERO-007, which combines two types of drugs (LABA and LAMA) often used for Chronic Obstructive Pulmonary Disease (COPD). Unlike many current treatments that use hand-held inhalers, this new medicine is designed to be given through a nebuliser, which turns liquid medicine into a fine mist you breathe in. This might be helpful for people who struggle with hand-held inhalers. Researchers want to understand how the body absorbs and processes this new medicine when given as a single dose, by comparing it to an existing treatment. This is done with healthy volunteers, not people with COPD, to safely gather important information about the drug's journey in the body.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

AeroRx Therapeutics Inc.

Enrolment target

Start

01 Sep 2026

Estimated completion

01 Dec 2026

COPD (Chronic Obstructive Pulmonary Disease)

What is this study about?

This research study is about a new way to deliver a medicine for Chronic Obstructive Pulmonary Disease (COPD). COPD is a lung condition that makes it hard to breathe. Many people with COPD use 'inhalers' which are hand-held devices that deliver medicine directly to the lungs.

This new medicine, called AERO-007, is different because it's designed to be used with a 'nebuliser'. A nebuliser is a machine that turns liquid medicine into a fine mist that you breathe in through a mask or mouthpiece. This can be easier for some people, especially those who find hand-held inhalers difficult to use effectively. The new medicine is a combination of two types of drugs (called LABA and LAMA) that are already known to help open up the airways in people with COPD.

This study is an early stage of research, called a 'Phase 1' study. It involves healthy volunteers, not people with COPD. The main goal is to understand how the body handles this new medicine – specifically, how much of the medicine gets into the bloodstream and how long it stays there, compared to a similar existing treatment. This information is important for making sure the medicine is safe and finding the right dose for future studies in people with COPD. At the moment, there isn't a combined LABA+LAMA medicine available that can be given by nebuliser, so this research could potentially fill an important gap.

Key takeaways

This is an early-stage study for a new COPD medicine, AERO-007.
The medicine is designed to be given by nebuliser, which might help people who struggle with standard inhalers.
It's being tested on healthy volunteers to see how their bodies handle the medicine.
The study aims to understand how much medicine gets into the bloodstream and for how long.
This research could pave the way for a new nebulised treatment option for COPD patients.

Who may be eligible?

This study is looking for healthy men and women aged between 18 and 55 years old.

To join, you would need to be generally in good health, as checked by doctors. This includes having good lung function, a healthy heart, and being within a certain weight range (BMI between 18 and 32). You must also be able to avoid alcohol for specific periods around your visits. Women who could become pregnant must agree to use effective birth control during the study and for a short time afterwards. Men with female partners who could become pregnant also need to use effective birth control.

People would not be able to join if they have any health condition that the doctors feel would make it unsafe for them to take part or affect the study results. This will be checked carefully by the study doctors.

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 55 years old?
Are you generally in good health?
Do you have good lung function (no history of serious breathing problems)?
Are you able to avoid alcohol for specific times during the study?
If female, are you able to use effective birth control if you could become pregnant?
If male, are you able to use effective birth control with a female partner who could become pregnant?

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. If you are, you would then have two separate treatment visits, each about 7 days apart. During each treatment visit, you would receive a single dose of either the new medicine or a comparison treatment, given through a nebuliser.

Before and after receiving the medicine, doctors and nurses would carry out various checks for about 24 hours. These checks include blood tests and measuring your vital signs (like blood pressure and heart rate). The total time you'd be involved in the study from your first visit to your last check-up would be around 2-3 weeks.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. For this early-stage study, the main benefit is contributing to medical knowledge that could help people with COPD in the future. As a healthy volunteer, you won't directly benefit from the medicine, as it's designed for people with a different health condition. Potential risks could include side effects from the study medicine, discomfort from blood tests, or unforeseen reactions. All procedures will be explained in full, and you'll be monitored closely. Remember, participation is completely voluntary, and you can withdraw from the study at any time without giving a reason, and it will not affect your future medical care.

Locations (1)

Medicines Evaluation Unit Ltd
Verified postcode
Manchester, United Kingdom

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a lung condition that causes breathing difficulties, often affecting people who have smoked or been exposed to lung irritants over a long time.

What is a nebuliser?

A nebuliser is a medical device that turns liquid medicine into a fine mist. You breathe this mist in through a mask or mouthpiece, allowing the medicine to reach your lungs.

Why is this study using healthy volunteers and not people with COPD?

Early-stage studies like this often use healthy volunteers first to safely understand how the body handles the new medicine and to check for any immediate side effects, before it's given to people with the condition it's designed to treat.

What does 'LABA+LAMA' mean?

These are types of medicines that help open up the airways in the lungs, making it easier to breathe. LABA stands for Long-Acting Beta-Agonist and LAMA stands for Long-Acting Muscarinic Antagonist. They work in different ways to achieve a similar goal.

Will I get paid to participate?

The information provided doesn't state if participants will be paid. This is a common question to ask the study team if you're interested.

How to find out more

Ahmet Tutuncu, MD, PhD

ahmet.tutuncu@aerorxtherapeutics.com +1-858-750-4717 Official trial record

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