A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria
This study is testing a new medicine called GTX-B001. It's a 'Phase 1' study, which means it's one of the first times this medicine is given to people. The main goal is to see if it's safe for healthy volunteers and people who suffer from a type of chronic hives called chronic inducible urticaria. This includes conditions like cold urticaria (hives from cold) and symptomatic dermographism (hives from scratching). Researchers will also look at how the body handles the medicine and if it starts to help with hive symptoms for those with chronic inducible urticaria, especially if their current antihistamine treatment isn't enough. The study involves a single dose of the medicine given through a drip, and participants will be followed for about 12 weeks.
At a glance
What is this study about?
This study is about a new potential medicine named GTX-B001, which is being investigated for treating a specific type of chronic hives known as chronic inducible urticaria. This condition causes people to develop itchy welts or hives when exposed to certain triggers, such as cold temperatures (cold urticaria) or even just scratching their skin (symptomatic dermographism).
If you have these conditions and find that regular antihistamines aren't fully controlling your symptoms, this study might be relevant. The first step for any new medicine is to make sure it's safe. This 'Phase 1' study is designed to do just that, by first giving a single dose of GTX-B001 to a small number of healthy volunteers, and then to people with chronic inducible urticaria. The researchers will be carefully watching for any side effects and how the body reacts to the medicine.
Beyond safety, the study also aims to understand how the medicine works in the body and if it shows any early signs of helping to reduce the symptoms of chronic inducible urticaria. This information is crucial for deciding if the medicine should be tested in larger studies in the future. It's important to remember that this is an early-stage study, so everyone involved will be closely monitored.
Key takeaways
- This is an early-stage study testing a new medicine (GTX-B001) for chronic inducible hives.
- The main goal is to check the medicine's safety in healthy people and those with specific types of hives.
- It also looks for early signs of whether the medicine helps with hive symptoms.
- Participants will receive a single dose of the medicine or a placebo through a drip.
- You'll have several visits over about 12 weeks for health checks and monitoring.
- The study involves a 'double-blind' approach, meaning you won't know if you get the active medicine or a dummy treatment.
Who may be eligible?
Researchers are looking for two main groups of people to take part. The first group includes healthy volunteers, aged 18 to 55, who are generally well and have no significant health problems. This part of the study helps researchers understand how the new medicine works in people without any other health conditions.
The second group is for people aged 18 to 75 who have chronic inducible urticaria – specifically cold urticaria or symptomatic dermographism – that they've had for at least three months. Importantly, their current antihistamine treatment should not be fully controlling their hives; they should still be experiencing hives and itching after exposure to their triggers within the last six weeks.
You wouldn't be able to join the study if you have any serious long-term illnesses like heart, lung, kidney, or liver disease, as these could affect your safety or the study's results. You also can't have taken part in another clinical trial with an experimental drug recently, or be on certain medications that affect your immune system, as these could interfere with how the study drug works.
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 between 18 and 55 (if healthy) or 18 and 75 (if you have chronic inducible hives)?
- Are you generally healthy, or do you have chronic inducible hives (like from cold or scratching) that aren't controlled by antihistamines?
- Have you been diagnosed with cold urticaria or symptomatic dermographism for at least 3 months?
- Have you *not* recently taken part in other drug trials or used certain immune-affecting medicines?
- Do you *not* have any serious long-term health conditions like heart, lung, or kidney disease?
What does participation involve?
If you decide to take part, the first step is a screening visit, which can last up to 4 weeks. During this time, doctors will carry out checks to make sure you're suitable for the study. If you're eligible, you'll receive a single dose of GTX-B001 through a drip, which will be given vào Day 1. Some participants will receive the active medicine, while others will receive a 'placebo' (a dummy treatment, like salt water) – this is decided randomly, and neither you nor the study team will know who gets what until the end of the study.
After receiving the medicine or placebo, you'll be carefully monitored for about 12 weeks. During this period, you'll have a total of 8 follow-up visits after your Day 1 treatment. These visits will involve health checks, blood tests, and for those with hives, specific tests to see how your hives are reacting to cold or scratching, and to see if the medicine is making a difference. The total time you'd be involved in the study, from screening to your last follow-up, would be around 14-16 weeks.
Potential risks and benefits
Locations (2)
- Charité Research Organization gmbhVerified postcodeBerlin, Germany· Recruiting
- Fraunhofer Institute For Translational Medicine And PharmacologyVerified postcodeBerlin, Germany· Not yet recruiting
Common questions
What is a 'Phase 1' study?
Phase 1 studies are the first stage of testing a new medicine in people. They mainly check if the medicine is safe and find the right dose, rather than focusing on how well it works.
What is 'chronic inducible urticaria'?
This is a type of long-lasting hives that are triggered by specific things, like cold temperatures (cold urticaria) or scratching your skin (symptomatic dermographism).
What is a 'placebo'?
A placebo is a dummy treatment, often made of salt water, that looks exactly like the study medicine. It helps researchers compare the effects of the real medicine.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor the doctors will know who is receiving the real medicine (GTX-B001) or the placebo until the study is over.
How long will I be in the study?
From your initial screening to your final follow-up, you would be involved for approximately 14 to 16 weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.