150 mg CIT-013 phase 1 trial
This early-stage clinical trial is testing an experimental medicine called CIT-013 given at a 150 mg dose. The study focuses on immune-mediated inflammatory diseases. These are long-term conditions, such as types of arthritis or bowel inflammation, where the body's immune system accidentally attacks healthy cells, causing pain, redness, and swelling. Because this is a phase 1 trial, its main purpose is to test safety. Researchers want to see how the human body breaks down the medicine and check for any side effects. It is not designed to cure an illness right away, but to find out if the treatment is safe enough for wider testing. The trial is open to adults aged 18 and over of any sex. Participants receive close medical supervision from a dedicated research team throughout the entire process.
At a glance
What is this study about?
Our immune system usually protects us from illness by fighting off germs and infections. In immune-mediated inflammatory diseases, however, the immune system becomes overactive and attacks healthy parts of the body instead. This can lead to ongoing inflammation, swelling, stiffness, and pain in joints, skin, or internal organs. Common examples include conditions like rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
This study is testing an experimental medicine called CIT-013 at a dose of 150 mg. Because it is a phase 1 trial, it represents one of the earliest stages of testing a drug in humans. The main goal is not yet to prove that the medicine relieves symptoms, but to check whether it is safe, to identify any side effects, and to watch how the body absorbs and clears it.
Early research like this is vital for developing new, better treatments. Many people living with inflammatory conditions find that existing medicines stop working well or cause unpleasant side effects. By testing new options such as CIT-013, scientists hope to lay the groundwork for future therapies that can improve daily quality of life.
Key takeaways
- Phase 1 trial testing the safety of a 150 mg dose of CIT-013.
- Aims to help develop new treatments for immune-related inflammatory conditions.
- Open to adults aged 18 and older of any sex.
- Involves regular clinic visits, health checks, and blood tests to monitor safety.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older of any sex. Depending on the exact study protocol, participants may either be healthy volunteers or individuals living with a diagnosed immune-mediated inflammatory condition.
Because safety is the top priority in phase 1 research, the medical team will carry out detailed health checks before anyone can join. People with severe heart, kidney, or liver problems, or those taking certain medications that interact with the immune system, may not be able to participate.
Women who are pregnant, planning to become pregnant, or breastfeeding are usually excluded from early-phase trials to protect the baby. The trial doctors will explain all specific requirements during the screening process.
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 at least 18 years of age.
- I am willing to attend clinic visits and undergo regular blood tests.
- I do not have severe untreated organ problems, such as major liver or kidney disease.
- I am not pregnant or breastfeeding.
- I am happy to talk with a research doctor about my medical history and medications.
What does participation involve?
Taking part begins with a screening appointment where doctors check your medical history, perform a physical examination, and take blood and urine samples. If you are eligible and agree to join, you will receive the study medicine, CIT-013, at a dose of 150 mg. You may be asked to stay at the clinic for observation or return for multiple follow-up visits so the medical team can monitor your vital signs, take regular blood tests, and ask about any side effects. The total duration of the study usually ranges from several weeks to a few months, and the team will track your health closely until the drug has completely cleared your body.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is a phase 1 clinical trial?
A phase 1 trial is an early study that tests a new medicine in a small group of people to see if it is safe, find the right dose, and check for side effects.
What are immune-mediated inflammatory diseases?
These are illnesses where the body's immune system mistakenly attacks healthy tissues, causing long-lasting swelling, soreness, and tissue damage.
Will taking part cure my condition?
No, early safety trials are not designed to cure diseases, though the findings may help scientists create effective treatments for the future.
Will my travel expenses be covered?
Most early-phase clinical trials offer reimbursement for reasonable travel and food costs, and some offer compensation for your time. The study team can give you full details.
Can I leave the study if I feel uncomfortable?
Yes, taking part is completely voluntary. You can withdraw your consent and leave the study at any point without it affecting your regular medical 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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