Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A phase 1, open-label trial in healthy subjects and in subjects with diabetes investigating pharmacokinetics, tolerability, safety, and food effect following single and multiple dosing of danegaptide

This research study is looking at a new medicine called danegaptide. It's a very early-stage study, meaning it's primarily designed to understand how the medicine works in the human body. Researchers want to see how much of the medicine gets into the blood, how long it stays there, and if it's safe and well-tolerated. They're also checking if eating food changes how the body absorbs the medicine. The study involves both healthy volunteers and people with diabetes. While this particular study isn't directly treating a condition, the information gathered is important for future studies that aim to develop treatments for diabetic retinopathy, an eye problem caused by diabetes.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Breye Therapeutics ApS

Enrolment target

Start

14 Mar 2025

Diabetic Retinopathy

What is this study about?

This study is a very early step in developing a new medicine called danegaptide. Think of it like taking a new car for its first test drive – the main goal is to see how it handles, if it's safe to drive, and how fuel-efficient it is, rather than trying to win a race yet.

For this new medicine, researchers want to answer some basic but very important questions. They need to find out how the body processes danegaptide: how much of it gets absorbed, how it travels through the body, and how quickly it's removed. They also need to make sure it's safe and doesn't cause too many side effects. This study will also check if eating food changes how the medicine works in the body.

This early stage of research is crucial because it helps scientists decide if a medicine is promising enough to move on to larger studies. The information from this study could eventually help in the development of treatments for diabetic retinopathy, which is an eye condition that can develop in people with diabetes and can sometimes lead to vision problems if not managed.

Key takeaways

This is an early-stage study (Phase 1) of a new medicine called danegaptide.
It's checking how the medicine works in the body and if it's safe.
Both healthy people and people with diabetes can take part.
The information helps researchers understand future potential for diabetic retinopathy treatment.
You would receive the medicine and have regular health checks.
Participation contributes to important medical research.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women can take part. The study is looking for two groups of people: healthy volunteers and people who have diabetes.

Being a 'healthy volunteer' means you don't have any major ongoing health problems. If you have diabetes, the research team will check if your diabetes is managed in a way that makes you suitable for the study.

They will have more specific rules about other health conditions or medicines that might mean you can't join, but these will be explained thoroughly if you express interest.

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 at least 18 years old?
Are you a man or a woman?
Have you been diagnosed with diabetes, or are you generally healthy?
Are you able to attend appointments at the study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, danegaptide. This would happen either once or several times over a period. You would need to attend the study clinic for appointments where the research team would monitor your health very closely. They would take blood samples to see how the medicine is moving through your body and ask you about any side effects you might experience. There might also be times when you take the medicine with or without food, so they can see if that makes a difference. The total duration of your involvement, including all visits and follow-up, would be fully explained by the study team.

Potential risks and benefits

The main benefit of taking part in this early study is that you would contribute to scientific knowledge, which could help develop new treatments for diabetic retinopathy in the future. However, as with any new medicine, there might be risks and side effects that are not yet fully known. The study team will explain all the potential risks they are aware of in detail, so you can make an informed decision. You are also free to leave the study at any time, for any reason, without needing to explain why, and this will not affect your usual medical care.

Locations (1)

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

—
Unverified
Sweden

Common questions

What is diabetic retinopathy?

Diabetic retinopathy is an eye condition that can affect people with diabetes, potentially leading to vision problems over time if not treated.

What does 'Phase 1 study' mean?

A Phase 1 study is a very early stage of testing a new medicine in people. Its main goal is to check how safe the medicine is and how the body handles it, rather than if it treats a disease.

Will this medicine treat my diabetes or eye condition?

No, this study is not designed to treat your diabetes or eye condition. It's focused on understanding the new medicine itself. Any future treatments would come from much later studies.

Do I have to pay to join the study?

No, you do not have to pay to join. All study-related care and medication are provided free of charge.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without it affecting your medical care.