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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Safety, tolerability and pharmacokinetics of intra‐articular (IA) single ascending dose of 4P‐004 in patient with Kellgren and Lawrence grade 2 to 4 osteoarthritic (OA) knee

This research is investigating a new treatment called 4P-004 for people who have knee osteoarthritis. Osteoarthritis is a common condition that causes joint pain and stiffness, especially in the knees. In this early-stage study, researchers are giving one dose of 4P-004 directly into the knee joint. They want to check if this new medicine is safe for people to use, how well their bodies tolerate it, and how the medicine behaves in the body (like how quickly it's absorbed and removed). The main goal is to make sure the treatment is safe before moving on to larger studies to see how well it works.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
4moving Biotech
Enrolment target
32
Start
23 Jun 2022

What is this study about?

This study is focused on a common condition called knee osteoarthritis. This is where the cartilage in your knee joint wears down over time, leading to pain, stiffness, and trouble moving. It can make everyday activities quite difficult. Unfortunately, while there are treatments to manage the symptoms, there isn't a cure yet, and researchers are always looking for new and better ways to help.

Here, scientists are testing a new medicine called 4P-004. They are giving it as a single injection directly into the knee joint. This is an early stage of testing, often called a 'Phase 1' study. At this point, the main concern isn't about whether the medicine cures the condition, but rather to carefully check if it's safe for people and how their bodies react to it. They also want to understand how the body processes the medicine – for example, how much of it reaches the knee and how long it stays there.

Understanding these basic things about safety and how the medicine works in the body is really important. It helps researchers decide if it's promising enough to continue testing in larger studies, which would then look into whether it helps reduce pain and improve movement for people with knee osteoarthritis. Every new medicine goes through these careful steps to ensure it is as safe and effective as possible.

Key takeaways

  • Tests new single-dose medicine 4P-004 for knee osteoarthritis.
  • Mainly focuses on safety and how the body handles the medicine.
  • Participation involves a single knee injection and follow-up visits.
  • Open to adults (18+) with moderate to severe knee osteoarthritis.
  • It's an early-stage study, so benefits are not guaranteed.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you must have been diagnosed with knee osteoarthritis. The doctors will determine the severity of your osteoarthritis using a specific scale (called Kellgren and Lawrence grade 2 to 4), which generally means you have moderate to severe changes in your knee joint.

There will be other specific health requirements and tests you'll need to meet to make sure the study medicine is safe for you. The study team will discuss all these details with you thoroughly.

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.

  1. Are you 18 years old or older?
  2. Do you have a diagnosis of knee osteoarthritis?
  3. Has a doctor told you your knee osteoarthritis is moderate to severe?
  4. Are you able to attend several clinic visits?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have screening tests to make sure you're a good fit for the study. If you qualify, you will receive a single injection of the study medicine, 4P-004, directly into your affected knee. After the injection, you would typically have several follow-up visits to the clinic. These visits might involve blood tests, physical examinations, and questions about how you're feeling and any changes in your knee pain or movement. The exact number and frequency of visits, as well as the total length of your participation in the study, would be fully explained to you by the research team.

Potential risks and benefits

Participating in a study like this might offer the potential benefit of accessing a new treatment that isn’t widely available yet. However, this is an early study, so it's not known if the medicine will help your symptoms, and it might not benefit everyone. There are also potential risks involved, such as discomfort or side effects from the injection itself, or from the new medicine. These could include pain, swelling, or bruising at the injection site, or other new symptoms. All known and potential risks will be discussed in detail with you before you commit. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What is osteoarthritis?

Osteoarthritis is a common condition where the protective cartilage on the ends of your bones wears down over time, causing pain, stiffness, and swelling in the joints, often in the knees.

What does a 'Phase 1' study mean?

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

Will this medicine cure my knee pain?

In this early study, we don't know if the medicine will cure or significantly reduce your knee pain. The main focus is on checking its safety.

How is the medicine given?

The medicine, 4P-004, is given as a single injection directly into your knee joint.

Can I stop participating if I want to?

Yes, absolutely. You can choose to leave the study at any time, for any reason, without it affecting your regular medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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