A multi-part, adaptive, Phase 1, first time in human study in healthy participants and participants with atopic dermatitis (AD) to assess the safety, tolerability, pharmacokinetics (PK) of single ascending (SAD), multiple ascending doses (MAD) and selected dose of SYX-5219 (AD Participants)
Atopic dermatitis, commonly called eczema, is a condition that makes the skin dry, red, itchy, and irritated. This Phase 1 trial tests a new investigational drug called SYX-5219. Because this medicine has never been given to people before, the main goal is to check its safety and see how the body absorbs, breaks down, and clears it. Researchers also want to monitor any side effects that might occur. The study starts with small doses in healthy volunteers. Over time, the dose is slowly increased to find an amount that is safe and well tolerated. Later parts of the study will test the medicine in adults who have atopic dermatitis. Adults aged 18 and over may be able to join. Taking part helps scientists discover whether this medicine could become a helpful new treatment option in the future.
At a glance
What is this study about?
Atopic dermatitis, commonly known as eczema, causes dry, red, and intensely itchy skin. For many people, existing creams and tablets do not provide enough relief, or they cause troublesome side effects. Because of this, scientists are working to develop new and more effective treatments that calm the skin.
This study is testing an experimental medicine named SYX-5219. It is a 'Phase 1' or 'first-in-human' study. This means it is the very first time the medicine is being tested in people. Before a medicine can be used as a treatment, doctors need to know how it acts inside the human body. The trial looks at safety, how well the body tolerates different doses, and how the drug moves through the bloodstream.
To keep everyone as safe as possible, researchers start by giving a very low dose to a small group. If that dose is safe, they slowly increase the amount for the next group. The trial will look at both healthy volunteers and people living with eczema to see if the medicine works similarly in both groups.
Key takeaways
- Phase 1 trial testing a new medicine called SYX-5219 for the first time in people.
- Open to both healthy volunteers and adults diagnosed with atopic dermatitis (eczema).
- Mainly focuses on finding safe doses and learning how the body handles the medicine.
- Participants must be 18 years of age or older.
- Taking part is voluntary, and you can withdraw at any point without losing your regular care.
Who may be eligible?
This trial is open to men and women aged 18 and over. Because it is split into different stages, researchers are looking for two groups of people: healthy volunteers and adults diagnosed with atopic dermatitis.
Healthy volunteers must not have any serious, long-term health conditions or skin issues. Volunteers joining the eczema group must have an active diagnosis of atopic dermatitis and meet certain criteria regarding the severity of their skin symptoms.
You might not be able to join if you are pregnant, breastfeeding, or taking certain medications that could interfere with the study medicine. The trial doctor will review your medical history and run standard health checks before you can take part.
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.
- I am aged 18 or older.
- I am either in good general health OR have a diagnosed history of atopic dermatitis (eczema).
- I am able and willing to attend scheduled appointments at the study clinic.
- I am not currently pregnant, breastfeeding, or planning to become pregnant during the trial.
- I am happy to have routine health checks, such as blood tests and heart traces.
What does participation involve?
Taking part will involve visiting a specialised clinical research clinic. If you join, you will receive doses of SYX-5219 under close medical supervision. The study team will track your health using common tests, such as blood and urine tests, blood pressure checks, and heart traces (ECGs). You will also have your skin examined if you are in the eczema group. You will need to attend several clinic visits, and some parts of the trial may require a short stay at the research unit so doctors can monitor you closely. The total time you spend in the study can vary from several weeks to a few months, including a follow-up period to make sure you remain well.
Potential risks and benefits
Locations (4)
- —UnverifiedGermany
- —UnverifiedBulgaria
- —UnverifiedIreland
- —UnverifiedDenmark
Common questions
What does 'first-in-human' mean?
It means the medicine has been tested thoroughly in laboratory settings, but this trial is the first time it is being given to people to test its safety.
Do I need to have eczema to take part?
Not necessarily. The study has different parts: some parts need healthy volunteers without eczema, while other parts are specifically for people with atopic dermatitis.
Will taking part cost me anything?
No, the study medicine and all tests are provided free of charge. Clinical trials often cover travel expenses or provide compensation for your time and inconvenience.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary. You can withdraw at any point, and your normal medical care will continue as usual.
Will this medicine cure my eczema?
No. This trial is primarily designed to check safety and find the right dose. It is too early to know how well the medicine works as a long-term treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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