A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and EU-Dupixent® in Healthy Adult Participants.
This research study is looking at a new medicine called CKD-706 and comparing it to a well-known medicine called Dupixent (both US and EU versions). The main goal is to understand how these medicines behave in the human body, what effects they have, and if they are safe when given to healthy adults. Doctors want to see if CKD-706 acts in a similar way to Dupixent, which is used to treat conditions like atopic dermatitis (a type of eczema). This is a very early-stage study, meaning it's the first time these comparisons are being made in people. Participants will receive a single dose of one of the medicines, and then researchers will carefully monitor their blood to learn more about it.
At a glance
What is this study about?
This study is an important first step in understanding a new medicine called CKD-706. Many medicines, especially those for conditions like severe eczema (atopic dermatitis), are complex. Before a new medicine can be used to treat patients, we need to understand how it works in the body and if it's safe. This particular study is comparing CKD-706 with Dupixent, a medicine already approved and used for eczema.
The main purpose is to see if CKD-706 acts in a very similar way to Dupixent when given to healthy people. This includes looking at things like how quickly the medicine gets into the bloodstream and leaves the body, how the body reacts to it, and if it causes any immune responses. By comparing it to Dupixent, researchers can get a good idea of whether CKD-706 has the potential to be a similar treatment option in the future.
It’s important to remember that this study is being conducted in healthy adults, not people with atopic dermatitis. This allows researchers to focus purely on how the medicine behaves without other health conditions complicating the results. The information gathered from this study will help decide if CKD-706 should be tested further in people who actually have conditions like atopic dermatitis.
Key takeaways
- Compares a new medicine (CKD-706) with an existing one (Dupixent) in healthy adults.
- Aims to understand how the new medicine behaves and if it's safe.
- One single dose of medicine will be given.
- Requires regular blood tests and follow-up for about three months.
- Crucial for future development of treatments for conditions like eczema.
- Your participation is voluntary and you can withdraw at any time.
Who may be eligible?
This study is looking for healthy adults between the ages of 18 and 55. To make sure the study results are clear and consistent, there are some specific health and lifestyle requirements. For example, your body weight and height (Body Mass Index) need to be within a certain range.
Because this is a very careful study, you can't have any major ongoing health problems or a history of serious illnesses. This includes conditions affecting your heart, liver, kidneys, or immune system. You also wouldn't be able to join if you've already taken Dupixent or similar medicines before.
For women, you cannot be pregnant, breastfeeding, or planning to become pregnant during the study. If you are a woman who could become pregnant, special birth control methods will be needed. For men, if your partner could become pregnant, you would also need to use two forms of birth control for several months during and after the study.
- Are you between 18 and 55 years old?
- Do you consider yourself generally healthy?
- Have you *never* taken Dupixent or similar medicines before?
- Are you able to commit to several clinic visits and blood tests over three months?
- If you are a woman, are you not pregnant, not breastfeeding, and willing to use specific birth control?
- If you are a man, are you willing to use specific birth control methods if your partner could become pregnant?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part, you'll first have a screening visit to check if you meet all the requirements. If you do, you'll be admitted to a special clinical unit on Day -1 (the day before dosing). On Day 1, you'll receive a single dose of either CKD-706, US-Dupixent, or EU-Dupixent. You won't know which one you're getting because the study is 'double-blind' – meaning neither you nor the researchers will know.
After receiving the medicine, you'll have regular blood tests for a long period, from Day 1 up to Day 85. These blood tests are crucial for understanding how the medicine moves through your body, what effects it has, and if your immune system reacts to it. You'll need to be available for the full study duration, which involves these regular follow-up visits and blood samples. The total duration of your participation will be from the initial screening until the final follow-up visit on Day 85.
Potential risks and benefits
Locations (2)
- Parexel EPCU BerlinBerlin, Germany· Not yet recruiting
- Parexel EPCU LondonLondon, United Kingdom· Recruiting
Common questions
What is atopic dermatitis?
Atopic dermatitis is a common, long-lasting skin condition also known as eczema. It causes dry, itchy, red, and inflamed skin.
What is Dupixent?
Dupixent is a medicine already approved and used to treat moderate to severe atopic dermatitis, as well as other conditions like asthma and nasal polyps.
Why are healthy people needed for this study?
Healthy volunteers help researchers understand how a new medicine works in the body without other health conditions affecting the results. This is often an important first step.
What does 'single-dose' mean?
It means you will only receive one dose of the study medicine, rather than taking it regularly over a period of time.
Will I know which medicine I received?
No, this is a 'double-blind' study, meaning neither you nor the study team will know which specific medicine you received (CKD-706, US-Dupixent, or EU-Dupixent) until after the study is complete.
How to find out more
Camilla Rincon
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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