Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Trial Investigating the pain-relieving properties of Lu AG06474 in Healthy Adult Participants

This research study is testing a new drug, Lu AG06474, to see how it affects pain. It's a very early-stage study, meaning we're mainly looking at how the drug works in the body and checking for any side effects in healthy adult volunteers. The aim is to understand if this new medication could be a safe and effective way to relieve pain in the future. We're not testing it on people who are already in pain at this stage. People aged 18 and over, both men and women, are invited to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

H. Lundbeck A/S

Enrolment target

Start

13 Sep 2023

Pain

What is this study about?

This study is about exploring a new medication known as Lu AG06474. Think of it as taking the first steps to understand if a new medicine could be helpful for pain relief. At this stage, we're not treating specific types of pain in patients. Instead, we're giving the drug to healthy adult volunteers to learn more about how it behaves in the human body.

The main goals are to find out if the drug is safe, what dose might be best, and how the body handles it. This kind of early research is really important because it helps scientists decide if a new drug is promising enough to be tested in larger studies with people who actually experience pain. It's a key step in developing new treatments for the future.

By taking part, healthy volunteers are helping us gather vital information that could one day lead to better ways to manage pain for many people. It's a foundational study that paves the way for future medical advances.

Key takeaways

Tests a new pain medication, Lu AG06474.
For healthy adult volunteers, not people with current pain.
Aims to understand safety and how the drug works.
All adults (18+) can take part.
Participation involves clinic visits and monitoring.
Your contribution helps future pain relief research.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. There is no upper age limit, so adults of any age are welcome to consider taking part.

Both men and women can participate in this research. The study needs a mix of healthy adults to get a good understanding of how the new drug, Lu AG06474, affects different people.

Remember, this study is for healthy volunteers, not people already experiencing pain. Specific health checks will be done to make sure you are suitable and safe to participate.

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 healthy?
Do you not currently experience chronic pain?
Are you happy to attend clinic appointments and stay for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you are suitable. This would involve a general health check. If you qualify, you would then attend a clinic for a number of visits, which might include staying overnight. During these visits, you would receive doses of the study medication, Lu AG06474, or a dummy treatment (placebo). We would take blood and urine samples and measure different things to see how your body reacts to the drug.

You would be carefully monitored by doctors and nurses throughout your time in the study. After your final dose of medication, there would be follow-up appointments to make sure you are well. The total time you would be involved in the study, including all visits and follow-ups, would be explained to you in detail before you agree to participate.

Potential risks and benefits

Participating in research studies like this can lead to important scientific discoveries that benefit many people in the future. However, there are no direct personal benefits for healthy volunteers taking part. There is always a chance of side effects from any new medication, and these would be carefully explained to you. The study team will monitor you closely for any reactions. You are completely 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.

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Unverified
Netherlands

Common questions

What is Lu AG06474?

It's a new medication being tested in the early stages to see if it could help with pain relief.

Will I definitely get the new medication?

Some participants will receive the new medication, while others might receive a dummy treatment (placebo) for comparison. You won't know which one you get.

Do I need to have pain to join?

No, this study is for healthy adults who do not currently have pain. We are studying how the drug works, not treating pain yet.

Is this study safe?

All studies go through strict safety checks. You will be closely monitored, and any potential risks will be fully explained before you decide to take part.

How long will I be involved?

The full duration, including visits and follow-ups, will be clearly explained to you by the study team before you commit.