A study in healthy subjects investigating the safety, tolerability and concentrations of FE 999301 after single and multiple doses
This study is an early step in testing a new medicine called FE 999301, which is being developed for conditions that cause inflammation in the gut, like Crohn's disease or ulcerative colitis. At this stage, the medicine is given to healthy men to see if it's safe and how well their bodies tolerate it. Researchers will also measure how much of the medicine stays in the body after a single dose and after taking it multiple times. This kind of study, often called Phase I, is crucial for understanding a new medicine before it can be tested in people who are actually ill. It helps make sure the potential treatment is safe enough for further research down the line.
At a glance
What is this study about?
Imagine your body sometimes overreacts and causes swelling, redness, and pain in your tummy or gut (this is called inflammation). This study is about a new potential medicine, known for now as FE 999301, that scientists hope could help people who have these kinds of problems, like inflammatory bowel disease. This is a very early study, meaning it's one of the first times this medicine is being given to people.
The main goal right now isn't to treat an illness, but to carefully check a few important things together:
Firstly, is FE 999301 safe for people? This is the most important question at this stage. Secondly, can people take this medicine without too many uncomfortable side effects? This is called 'tolerability'. Lastly, the study will look at what happens to the medicine once it's in the body – how much is absorbed, how it's changed, and how quickly it leaves. They'll measure this after giving a single dose and then after giving it a few times over a period. This information is vital before the medicine can be tested in people who actually have gut inflammation.
Key takeaways
- This is an early-stage (Phase I) study of a new medicine, FE 999301.
- It's for healthy men, aged 18 and older.
- The main goals are to check the medicine's safety and how the body handles it.
- Participation involves taking the medicine and regular health checks.
- You'll be helping medical research, but there's no direct health benefit to you.
- You can stop participating at any time.
Who may be eligible?
This study is specifically looking for healthy volunteers. To be able to take part in this study, you must be a male and be at least 18 years old. There is no upper age limit mentioned, meaning men of any age over 18 might be considered.
The study is designed to gather information on a new medicine in people who don't have any specific health problems. This helps the researchers understand the medicine's basic effects without other illnesses complicating the results. If you have any ongoing health conditions, even mild ones, you would likely not be able to join this particular study.
Because this is a very early study, the requirements for who can take part are usually quite strict to ensure the safety of the volunteers and to get the clearest possible results about the new medicine.
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 male?
- Are you 18 years old or older?
- Are you generally healthy, without significant ongoing medical conditions?
- Are you willing to attend multiple clinic visits and follow study procedures?
What does participation involve?
If you decide to take part in this study, you would first go through a screening visit. This visit helps the study team check if you meet all the requirements. It would involve medical tests and a review of your health history. If you are suitable, you would then be given the study medicine, FE 999301. This would happen over a set period, where you would receive either a single dose or multiple doses, depending on the part of the study you participate in.
Throughout the study, you would have regular appointments where the doctors and nurses would monitor your health. They might take blood samples, check your vital signs (like blood pressure and heart rate), and ask you how you are feeling. This is to carefully track how your body reacts to the medicine and to measure the amount of the medicine in your system.
The full duration of your participation, including all visits and follow-up, would be fully explained to you before you agree to join. You would typically need to attend various clinic visits over several weeks or months. All visits, tests, and medicines related to the study would be provided free of charge.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What kind of medicine is FE 999301?
FE 999301 is a new medicine being developed to treat problems like inflammation in the gut, but this study focuses on its safety and how the body handles it in healthy people.
Will I get better if I join this study?
No, this study is for healthy volunteers and is designed to test the medicine's safety, not to treat any illness. There's no direct health benefit for you.
Do I have to pay to be in the study?
No, all study-related visits, tests, and the medicine itself are provided free of charge.
What is 'Phase I' of a clinical trial?
Phase I is the very first stage where a new medicine is given to people, usually healthy volunteers, to check if it's safe and how the body processes it.
Can women join this study?
No, this particular study is only open to healthy male volunteers.
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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