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

A first human dose study to assess the safety, tolerability, pharmacokinetics and target engagement of single doses of NNC6022-0001 in healthy adults

This is a very early-stage study, often called a 'first human dose' study. It's designed for healthy adult volunteers and aims to carefully check a new medicine called NNC6022-0001. This medicine is being developed to help with cardiometabolic diseases, which affect the heart and how your body uses energy. Researchers want to see if the medicine is safe when given in single doses, how long it stays in the body, and if it acts on the body in the way they expect. Because it's so early, it's about understanding the basics of this new medicine before it's tested in people with the actual health conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novo Nordisk A/S

Enrolment target

Start

11 Mar 2024

Cardiometabolic diseases

What is this study about?

This research study is one of the very first times a new medicine, known for now as NNC6022-0001, will be given to people. This kind of study is really important because it helps scientists understand if a new medicine is safe enough to be developed further.

The main goal is to find out if NNC6022-0001 is safe and well-tolerated by healthy adults when given a single dose. 'Well-tolerated' means checking for any side effects and seeing how people feel after taking the medicine. Researchers will also look at how the body absorbs, breaks down, and gets rid of the medicine. This is called 'pharmacokinetics.' They also want to see if the medicine reaches and affects the right parts of the body, which they call 'target engagement.' This information is crucial for deciding if NNC6022-0001 has the potential to help people with conditions affecting their heart and metabolism.

Cardiometabolic diseases are terms for a group of health issues that can affect your heart, blood vessels, and how your body processes energy and sugar. Examples include things like type 2 diabetes and heart disease. While this study doesn't involve people who currently have these conditions, the information gathered here is a vital first step towards potentially creating a new treatment option for them in the future. It helps lay the groundwork for later studies that would test the medicine in patients with these specific health problems.

Key takeaways

This is a very early-stage safety study of a new medicine.
It's for healthy adult volunteers, aged 18 and over.
The medicine (NNC6022-0001) is being developed for heart and metabolism problems.
You will receive a single dose of the medicine.
The study aims to check safety, how the body handles the medicine, and if it works as expected.
Your contribution could help develop future treatments.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. There is no upper age limit, as long as you meet all the other health requirements.

Both men and women are welcome to take part in this research. The study team will carefully check your overall health to make sure it's safe for you to participate.

Because this is a study for healthy volunteers, the most important thing is that you do not have any significant ongoing medical conditions that could affect how the medicine works or your safety during 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?
Do you consider yourself a healthy adult with no major ongoing medical conditions?
Are you a man or a woman?
Are you able to attend all required study visits and follow the study instructions?
Are you comfortable with blood tests and other health checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given a single dose of the study medicine, NNC6022-0001. The number of hospital visits will depend on the study design, but typically, in these early-stage studies, you might stay overnight for observation after taking the medicine, or have several follow-up visits over a few days or weeks. During these visits, the study team will carry out health checks, which could include blood and urine tests, heart scans (like an ECG), and asking you how you're feeling. There will be careful monitoring to make sure you're safe and to see how your body reacts to the medicine. The total length of your participation, from your first visit to your last follow-up, will be explained fully by the study team, but these first-in-human studies usually last from a few days to a few weeks.

Potential risks and benefits

Participating in any research study has potential benefits and risks. The main benefit here is contributing to medical science and helping to develop new treatments that could one day help many people with heart and metabolism conditions. You will also receive careful medical monitoring. As for risks, because this is a new medicine, there's always a chance of unexpected side effects, though the doses given are usually very low. The study team will explain all known potential risks and monitor you closely. Remember, your participation is completely voluntary, 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 does 'first human dose study' mean?

It means this is one of the very first times this new medicine is being given to people, usually healthy volunteers, to check its basic safety.

Why are healthy adults taking part if the medicine is for heart conditions?

Healthy adults are involved in these early studies to first understand how the medicine behaves in the body and if it's safe, before testing it in people who are already unwell.

Will I receive the actual medicine or a dummy pill?

This study focuses on giving the active medicine (NNC6022-0001) in single doses to healthy volunteers to understand its effects, so you would receive the actual medicine.

How long will I need to be in the study?

The total time you spend in the study, including visits and follow-ups, will be fully explained by the study team, but these studies typically last from a few days to a few weeks.

Will I be paid for taking part?

It is common for volunteers in early-phase studies like this to receive some payment for their time and inconvenience. The study team will provide details on this.