Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A controlled, randomized, first-in-human study of AP31969 investigating single and multiple ascending doses and the effect of food in healthy subjects

This research is looking at a new medicine called AP31969. It's the very first time this medicine is being given to people. The main goal is to check how safe it is and how the body handles different doses. Researchers will also look at whether eating food makes a difference to how the medicine works. This study involves healthy volunteers, not people who are unwell. This is a very early stage of testing, and the results will help guide future studies for people with a common heart condition called atrial fibrillation, which causes an irregular heartbeat.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Acesion Pharma ApS

Enrolment target

142

Start

28 Aug 2023

Atrial Fibrillation (cardiac arrhythmia)

What is this study about?

This study is about a new medicine called AP31969. It's a very early-stage research project, which means it's the first time this particular medicine is being given to people. The main aim is to understand how safe it is and how the human body reacts to it. Think of it like taking a new car for its first test drive – you want to make sure it's safe to drive and see how it performs.

The researchers will be giving different amounts (doses) of the medicine to volunteers to find out what amount is safe and how our bodies process it. They also want to see if eating food at the same time changes how the medicine works. This kind of study, called a 'Phase 1' study, is crucial for any new medicine because it helps us learn the basic facts about safety and how it behaves in humans before it can be given to people who are actually unwell.

While this study is done in healthy volunteers, the ultimate goal of developing AP31969 is to help people with a heart condition called atrial fibrillation. This condition causes an irregular and often very fast heartbeat. Understanding the new medicine's safety and how it works in healthy people is a vital first step towards potentially offering a new treatment option for those living with atrial fibrillation in the future.

Key takeaways

This study is testing a brand-new medicine, AP31969, for the first time in people.
It aims to check the medicine's safety and how different doses work in healthy volunteers.
Researchers also want to see if food affects how the medicine is absorbed.
This is an early step towards potentially treating an irregular heartbeat called atrial fibrillation.
Participation helps advance medical science, even if there's no direct benefit to you.

Who may be eligible?

This study is looking for healthy adults to take part. To be considered, you need to be 18 years old or older. There is no upper age limit for volunteers in this study. Both men and women can participate.

Since this is a study for healthy individuals, people who have significant ongoing health problems or are currently taking certain medications would likely not be able to join. The research team will do thorough checks to make sure everyone who takes part is suitable and healthy enough for the study.

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 willing to follow study instructions carefully?
Do you understand the commitment involved in a research study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new study medicine, AP31969, at different doses. You'd also likely have blood tests, urine tests, and possibly heart checks (like an ECG) to see how your body reacts to the medicine and to monitor your health. You would have regular visits to the clinic, and some visits might involve staying overnight for a period. The total time you would be involved in the study, including all visits and follow-up, would be made clear by the study team.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might not directly benefit from this early-stage study, but your participation is vital in helping to advance medical knowledge and find new treatments for serious conditions like atrial fibrillation. Potential risks could include side effects from the new medicine, which can be mild, like headaches or nausea, or more serious. The research team will monitor you closely, and 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
Netherlands

Common questions

What is atrial fibrillation?

Atrial fibrillation is a common condition where the heart beats with an irregular and often very fast rhythm.

What does 'first-in-human' mean?

It means this is the very first time this new medicine is being given to people, after extensive testing in the lab and in animals.

Why do studies use healthy volunteers?

Using healthy volunteers helps researchers understand how a new medicine works in the body and its common side effects without the complications of an existing illness or other medications.

Will I get paid for taking part?

Study participation often includes payment for time and travel, but specific details would be provided by the research team.

What is an 'ascending dose' study?

This means that small groups of volunteers will receive progressively higher doses of the medicine to find out at what level it is safe and well-tolerated.