Study in healthy volunteers to compare the blood levels after epoetin alfa (Blau EPO) and Erypo, administered as a single intravenous injection as well as safety, tolerability and the effects on certain blood values.
This research study is for healthy volunteers and aims to compare two medicines, Blau EPO and Erypo. Both medicines are designed to treat anaemia that can happen if you have long-term kidney problems. The study will give volunteers a single dose of one of the medicines into their vein. Researchers will then check blood levels to see how the medicines move through the body. They also want to understand if the medicines have any side effects and how well people tolerate them. This helps doctors learn more about how these treatments work. It's important to remember this study is about understanding the medicines, not about treating anyone's anaemia.
At a glance
What is this study about?
This study is a research project looking into two similar medicines called Blau EPO and Erypo. These medicines are used to help people who have anaemia – a condition where you don't have enough red blood cells – especially when it's caused by long-term kidney disease. The main goal of the study is to see how these two medicines behave in the body after they are given through a drip into a vein. Researchers will measure the levels of the medicine in the blood over time.
Because this is the first kind of study for these medicines, it's called a 'Phase I' study. This means it's about understanding the basics: how safe the medicines are, if people can tolerate them without too many problems, and how they affect certain simple blood tests. It's not about seeing if the medicines cure a disease; it's about gathering initial information in healthy people before they might be tested in patients who actually have anaemia.
The findings from this study will help doctors and scientists understand if Blau EPO and Erypo are similarly absorbed and processed by the body. This information is really important for developing new medicines and making sure they are as safe and effective as possible for future patients. By taking part, healthy volunteers contribute valuable information to medical science.
Key takeaways
- This study is testing two medicines (Blau EPO and Erypo) in healthy adults.
- It aims to compare how the medicines move through the body and check their safety.
- The medicines are for anaemia linked to long-term kidney problems, but this study is not treating that condition.
- Participants will receive a single dose and have several blood tests and check-ups.
- Your involvement helps medical science understand these treatments better.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To be able to take part in this study, you need to be a healthy adult. This means you should generally be in good health and not have any serious ongoing medical conditions. The study is looking for both men and women to participate.
You must be at least 18 years old to join. There isn't an upper age limit mentioned, but you would still need to meet the general health requirements.
Also, because it's a study for healthy people, you won't be able to take part if you already have the blood condition (anaemia) that these medicines are designed to treat, or other significant illnesses.
- Are you 18 years old or older?
- Are you generally in good health?
- Do you have any serious ongoing medical conditions?
- Are you currently pregnant or breastfeeding?
- Are you able to attend several study visits, including blood tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will receive a single dose of either Blau EPO or Erypo, which will be given to you as an injection into a vein (like a drip). Before and after this, you will have several visits to the study clinic. During these visits, the research team will take blood samples to measure the medicine levels and check other blood values. They will also monitor your general health very closely to see how you are tolerating the medicine and if you experience any side effects. You will be observed for a period after the dose, and there will likely be follow-up visits over several days or weeks. The total time you would be involved in the study, from your first screening visit to your last follow-up, would be fully explained before you agree to join.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is anaemia?
Anaemia is a condition where your blood doesn't have enough healthy red blood cells to carry oxygen around your body. It can make you feel tired and weak.
What is a Phase I study?
A Phase I study is the first step in testing a new medicine in people. It mainly checks how safe the medicine is, how it moves through the body, and what dose might be best, usually in a small number of healthy volunteers.
Will I get paid for taking part?
The information provided doesn't say if you will be paid. You should ask the study team about any compensation or reimbursement for travel and time.
Will I know which medicine I receive?
Sometimes in these studies, participants and even the doctors don't know which medicine is given until after the study is over. This helps ensure fair results. You should ask the study team how this works in this specific trial.
What are 'blood values'?
Blood values refer to what's found in your blood samples, such as the number of red blood cells, white blood cells, and other elements. Doctors look at these to check your health and how a medicine might be affecting you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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