Study in healthy male participants to compare the blood levels after epoetin alfa (Blau EPO) and Erypo, administered as multiple intravenous injections as well as safety, tolerability and the effects on certain blood values.
This study is for healthy men and is looking at a new version of a medicine called epoetin alfa, sometimes known as Blau EPO. This medicine is used to treat anaemia, a condition where your blood doesn't carry enough oxygen, particularly when it's caused by long-term kidney problems. The researchers want to compare how this new version behaves in the body and its safety, compared to an existing medicine called Erypo. They will give participants several injections and take blood samples to measure how much medicine is in the blood and if it affects other key blood levels. This is an early stage study to make sure the new medicine is safe and well-tolerated.
At a glance
What is this study about?
This study is an important first step in understanding a new version of a medicine called epoetin alfa (which they're calling Blau EPO). Epoetin alfa is a type of medicine that helps your body produce more red blood cells. These cells are really important because they carry oxygen around your body. People with long-term kidney problems often develop anaemia, meaning they don't have enough red blood cells, which can make them feel tired and unwell. This medicine helps to treat that.
The main goal of this study is to see how this new version of epoetin alfa acts in the body compared to a similar, existing medicine called Erypo. The doctors want to find out if the new medicine reaches similar levels in the blood and stays there for a similar amount of time after an injection. They will also be carefully watching for any side effects and checking if it affects other important blood values.
Because this is an early stage study, it's being done in healthy male volunteers. This helps the researchers to understand how the medicine works in the body without other health conditions making things more complicated. The information gathered from this study will help decide if this new medicine is safe and effective enough to be tested in larger groups of patients in the future.
Key takeaways
- This study is testing a new version of a medicine for anaemia.
- It's an early-stage study for healthy male volunteers.
- They are comparing it to an existing medicine given by injection.
- The main goals are to check blood levels, safety, and how well it's tolerated.
- Information from this study will help decide if it can be tested in patients later.
Who may be eligible?
This study is specifically looking for healthy male volunteers. You'll need to be at least 18 years old to take part. There isn't an upper age limit mentioned, so older men may also be able to join.
To be considered healthy, you would generally need to be free from any major ongoing illnesses or conditions. The study team will do some checks to make sure you're healthy enough to participate.
They are not looking for women or people under 18, and if you have significant health problems, especially kidney-related issues, this study would not be suitable for you.
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?
- Do you consider yourself generally healthy?
- Are you willing to have multiple injections into your vein?
- Are you able to attend regular clinic visits?
What does participation involve?
If you decide to take part, you'll receive several injections of either the new epoetin alfa or the existing medicine, Erypo. These injections will be given directly into your vein. Throughout the study, you'll have regular visits to the clinic where doctors and nurses will take blood samples to check the levels of the medicine, as well as other important blood values.
The medical team will carefully monitor you for any side effects or reactions to the medicine. They will also look at how well you tolerate the injections. The full duration of your participation, including all visits and follow-up, will be explained in detail by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is epoetin alfa?
It's a medicine that helps your body make more red blood cells, which carry oxygen around your body.
Why is this study only for men?
This is an early stage study, and sometimes they start with one sex to simplify the research and understand how the medicine works before testing it more widely.
Will I feel sick after the injections?
The study team will monitor you closely for any side effects, including feeling sick or any other reactions. They will explain common side effects beforehand.
Do I have to pay to be in the study?
No, you do not have to pay to participate in a clinical trial. All study-related care and medicines are provided free of charge.
What's the difference between this new medicine (Blau EPO) and Erypo?
Blau EPO is a newer version of the medicine, and the study wants to see if it behaves in the body in a similar way to the existing medicine, Erypo, and if it's just as safe.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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