Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A two-part, open-label study to assess the pharmacokinetics, pharmacodynamics and safety of single doses of inhaled and intravenously administered D,L lysine acetylsalicylate • glycine (LASAG) in healthy adult subjects: Study Part A follows a randomized, cross-over design to compare three dose levels of inhaled LASAG to one dose level of intravenously administered LASAG and Study Part B follows a single group design to investigate a XXXXX LASAG inhalation solution.

This is an early research study, often called a Phase I trial. It's designed to understand how a new form of medicine for migraines, called LASAG, works in healthy adults. Researchers are testing two ways to give the medicine: a simple inhaled spray (like an asthma inhaler) and through a drip into your arm (intravenous). The main goal is to see how the body handles the medicine and whether it's safe at different doses. They'll also look at how effective it is within the body. This study helps doctors learn more before testing the medicine in people who actually have migraines.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Aspiair GmbH

Enrolment target

Start

19 May 2023

Phase I Clinical trial in healthy males and females intended indication: migraine

What is this study about?

Imagine you have a new headache medicine, but you want to find the best and safest way to get it into your body. That's essentially what this study is all about. Researchers are taking a medicine currently used for migraines and exploring two different ways to give it: one is through a simple inhaler, like a breath you take, and the other is through a drip into your vein. The medicine itself is called LASAG.

This is a 'Phase I' study, which means it's one of the first times this specific way of giving the medicine is being tested in people. Because it's so early, they choose healthy adults (people who don't have migraines or other major health problems) to take part. This helps them understand how the medicine behaves in the body without other illnesses making things complicated. They want to see how much medicine gets into the bloodstream, how quickly it's used up, and if there are any side effects.

By carefully studying these things, doctors can decide if this new way of giving LASAG is promising enough to continue testing in people who suffer from migraines. It's a crucial step to make sure any future treatments are both effective and as safe as possible.

Key takeaways

This is an early study (Phase I) for a new way to give migraine medicine.
It's testing an inhaled spray and an IV drip.
Healthy adults aged 18+ can take part.
The main goals are to check safety and how the medicine works in the body.
You won't directly get treatment for migraines in this study.
Participation involves multiple visits and monitoring.

Who may be eligible?

This study is looking for healthy adult volunteers, both men and women, who are 18 years old or older. You don't need to have migraines to take part, as the study is focusing on how the medicine works in a healthy person's body.

If you have any significant ongoing health conditions or are taking certain medications, you might not be able to join. The research team will ask you questions about your health and do some checks to make sure the study is a good fit for you.

Essentially, they're looking for clear, healthy individuals to help them understand this new medicine properly.

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 18 years old or older?
Are you generally in good health?
Are you able to attend multiple study visits?
Are you willing for blood samples to be taken?
Are you comfortable with receiving medicine through a drip and an inhaler?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine in different ways and amounts over a few visits. In one part of the study, you'll receive the medicine as an inhaled spray and through a drip in your arm, but not at the same time. This is done with breaks in between each treatment period.

During your visits, doctors and nurses will monitor you closely. They'll regularly take blood samples to see how the medicine is moving through your body, and they'll check your vital signs like blood pressure and heart rate. They'll also ask you about any feelings or side effects you experience. The overall length of your participation, including all visits and follow-up, will be explained in detail before you agree to join.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is helping researchers learn more about a new way to deliver migraine medicine, which could eventually lead to better treatments for others. However, as a healthy volunteer, you may not directly benefit from the medicine itself. Potential risks include discomfort from blood samples or drips, and possible side effects from the study medicine, though these will be closely monitored. You have the right 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
Germany

Common questions

What does 'Phase I' mean?

Phase I means it's one of the first times a new medicine or way of giving medicine is tested in people, usually healthy volunteers, to check safety and how it works in the body.

Do I need to have migraines to join this study?

No, this study is for healthy men and women. They want to see how the medicine works without other health conditions affecting the results.

What does 'inhaled' mean?

'Inhaled' means you breathe the medicine in, usually through a special device that creates a mist or spray.

What does 'intravenously administered' mean?

This means the medicine is given directly into your vein, usually through a small tube in your arm, often called an 'IV drip'.

Will I know if I'm getting the active medicine or a dummy treatment?

No, this study is 'open-label', meaning both you and the study team will know which dose of the active medicine you are receiving or how it's being given. There isn't a dummy treatment in this study.