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

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Injections of NNC0582-0001 in Healthy Adults

This research study is investigating a new medicine called NNC0582-0001. Healthy adult volunteers will receive a single injection of this medicine under their skin. The main goals are to find out if the medicine is safe, how well people tolerate it (meaning if they experience side effects), and how the medicine moves through and is processed by the body. This is a very early-stage study, known as Phase I, which means it's the first time NNC0582-0001 is being given to humans. Understanding these basic things helps researchers decide if it's safe to continue developing the medicine further.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novo Nordisk A/S

Enrolment target

Start

17 Jun 2024

Healthy Volunteers

What is this study about?

This study is looking into a brand new medicine, which we'll call NNC0582-0001. It's designed to understand how this medicine works in the human body for the very first time. You might be wondering why healthy volunteers are needed for this type of research. It's because when a new medicine is first tested, doctors want to see how it behaves in bodies that aren't already affected by other health conditions or medicines. This helps them get a clear picture of its effects.

The main things the researchers want to find out are: Is NNC0582-0001 safe? What are the possible side effects, and how well do people tolerate them? They also want to learn how the body takes in the medicine, how it's used, and how it leaves the body. This is a bit like tracking a journey – from when the medicine enters your body to when it's gone.

This is a very early stage of medicine testing, called a Phase I study. It's a crucial step before the medicine can be tested in people who have a particular illness. The findings from this study will help decide if it's safe and worthwhile to continue developing NNC0582-0001 further.

Key takeaways

This is an early study of a new medicine (NNC0582-0001).
It's the first time this medicine is being tested in humans.
The main aims are to check safety and how the body deals with the medicine.
Healthy adults, aged 18 and over, are needed.
Participation involves a single injection and clinic visits for monitoring.
Your health will be closely watched throughout the study.

Who may be eligible?

This study is looking for healthy adults. This means you should generally be in good health and not have any ongoing medical conditions that could interfere with the study or the medicine being tested. The researchers will carry out checks to make sure you are suitable.

To be considered, you must be 18 years old or older. There is no upper age limit, meaning people of all adult ages can potentially take part. Both men and women are welcome to participate in this 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.

Am I at least 18 years old?
Do I consider myself generally healthy?
Am I willing to receive a single injection?
Can I attend several follow-up appointments at a clinic?
Am I able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single injection of the study medicine, NNC0582-0001, just under your skin. Throughout the study, you would attend several appointments at the research clinic. During these visits, the research team would closely monitor your health, take blood and urine samples, and ask about any new symptoms or side effects you might be experiencing. The total duration of your involvement in the study would depend on how long the researchers need to track the medicine in your body. This 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 could be contributing to medical science and helping to develop new treatments, even if you don't personally gain direct health benefits. As this is a first-in-human study, there might be unknown side effects or reactions to the new medicine. The research team will explain all known risks and closely monitor participants for any issues. You are free 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.

—
Unverified
Austria

Common questions

What is NNC0582-0001?

It's a new medicine that researchers are testing for the very first time in people.

Why are healthy people needed for this study?

Testing new medicines in healthy people helps researchers understand how they work in the body without other health problems getting in the way.

How will the medicine be given?

It will be given as a single injection just under the skin, similar to some common vaccines.

What is the main goal of this study?

The main goal is to find out if the new medicine is safe and how the body handles it.

Can women take part in this study?

Yes, both men and women are welcome to participate, as long as they meet the other study requirements.