RecruitingPHASE1INTERVENTIONAL

Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants With IPF

This research study is investigating a new inhaled medication called AGMB-447. It's designed for people with idiopathic pulmonary fibrosis (IPF), a serious lung condition. The main aim is to understand if AGMB-447 is safe, how well the body tolerates it, and how it behaves in the body. The study will include both healthy volunteers and individuals already diagnosed with IPF. Participants will receive either the active medicine or a 'placebo' (a dummy treatment with no active drug) through a nebulizer. This early-stage trial is crucial for gathering basic information to see if AGMB-447 could be a future treatment option for IPF patients. We are not making any medical claims or recommendations about this potential treatment.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Agomab Spain S.L.

Enrolment target

145

Start

01 Dec 2023

Estimated completion

01 Jun 2026

IPF

What is this study about?

This research study is testing a new medicine called AGMB-447, which is given by inhaling it (using a nebulizer). The purpose is to see if this new medicine is safe, how well people tolerate it, and how it works in the body. This is an early phase of testing, which means it’s one of the first times this medicine is being given to people. The study includes both healthy volunteers and people who have a lung condition called Idiopathic Pulmonary Fibrosis (IPF).

Idiopathic Pulmonary Fibrosis (IPF) is a chronic and progressive lung disease where the lungs become scarred and thicken, making it harder to breathe. There's currently no cure for IPF, but treatments are available to help manage the condition and slow its progression. Finding new and effective treatments is very important, and this study aims to gather initial information about AGMB-447 to see if it has the potential to help people with IPF in the future.

In this study, some participants will receive AGMB-447, while others will receive a 'placebo.' A placebo looks just like the real medicine but contains no active drug. This allows the researchers to compare the effects of AGMB-447 against doing nothing, helping them understand if any changes observed are due to the medicine itself. We want to stress that participating in a clinical trial does not mean you will receive a proven treatment, and you should always discuss any medical decisions with your doctor.

Key takeaways

Tests a new inhaled medicine, AGMB-447, for IPF.
Includes both healthy volunteers and people with IPF.
Compares AGMB-447 to a dummy treatment (placebo).
Focuses on safety, tolerability, and how the medicine works in the body.
Participation involves regular clinic visits and health checks.
Your involvement could help future IPF treatments.

Who may be eligible?

For healthy volunteers, you could be considered if you are male or female, aged between 18 and 55 years old. You need to be generally healthy, as determined by a medical examination and tests, with normal lung function.

If you have IPF, you might be eligible if you are male or female and over 40 years old. You must have a confirmed diagnosis of IPF that meets specific medical guidelines. You could be either taking a stable dose of a common IPF medicine (Nintedanib) for at least three months, or not currently taking any anti-fibrotic medication for IPF. If you stopped medication, it must not have been due to it not working, and you must have stopped at least six weeks before screening.

All participants will need to meet certain health and lung function criteria, including specific measurements for lung capacity and other tests, as assessed by the study doctor during screening. A full list of criteria will be discussed with you by the research team.

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 (for healthy volunteers)?
Are you over 40 years old with a confirmed IPF diagnosis?
Do you currently take Nintedanib for IPF, or no anti-fibrotic medication at all?
Are you generally in good health (for healthy volunteers)?
Are you willing to attend regular clinic visits and undergo health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study involves several stages. It's divided into three parts: A, B, and C. Parts A and B involve healthy volunteers, while Part C is for participants with IPF. You will be given the study medicine, AGMB-447, or a placebo, using a nebulizer, which turns liquid medicine into a fine mist you breathe in.

Assessments will include regular health checks, physical examinations, blood tests, and lung function tests (like spirometry to measure how much air you can breathe out). These will be done at specific visits, which will involve staying at the study clinic for a period. Researchers will be monitoring you closely to see how your body handles the medicine and how it affects you. You will also have follow-up appointments after you finish taking the study medicine. The exact number of visits and the total duration of your participation will depend on which part of the study you are in, but the research team will provide all these details.

Potential risks and benefits

Participating in any research study comes with potential benefits and risks. You might not directly benefit from taking part in this study, as the main goal is to gather information about the new medicine. However, you would be contributing to medical research that could help others with IPF in the future. Potential risks could include side effects from the study medicine or the procedures involved, such as discomfort from blood tests or monitoring. All potential risks will be thoroughly explained by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Medicines Evaluation Unit Ltd. an IQVIA business
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is AGMB-447?

AGMB-447 is a new experimental medicine being tested to see if it could be a treatment for Idiopathic Pulmonary Fibrosis (IPF).

What is a 'placebo'?

A placebo is a dummy treatment that looks exactly like the study medicine but contains no active ingredients. It's used to compare against the real medicine.

Who can take part in this study?

The study is looking for both healthy volunteers aged 18-55 and people with a confirmed diagnosis of IPF over 40 years old, who meet specific health criteria.

How will the medicine be given?

The medicine will be given using a nebulizer, which means you will breathe it in as a fine mist.

Can I stop participating if I change my mind?

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

How to find out more

Tim Van Kaem

clinicalstudies@agomab.com 0032 3318 91 70 Official trial record

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