A RANDOMIZED, DOUBLE-BLIND, THREE-PART, TWO-PERIOD, TWO-SEQUENCE, SINGLE-DOSE, CROSS-OVER STUDY TO COMPARE THE PHARMACOKINETICS (PK), SAFETY AND IMMUNOGENICITY PROFILE OF MB04 (PROPOSED ETANERCEPT BIOSIMILAR), EU-SOURCED ENBREL® AND US-LICENSED ENBREL® IN HEALTHY MALE VOLUNTEERS.
This study is looking at a new version of a well-known medicine, called MB04, which is similar to Enbrel. Enbrel is often used for conditions like arthritis. We want to see how MB04 acts in the body compared to the original Enbrel, specifically comparing both European and US versions of Enbrel. This involves giving healthy male volunteers a single dose of each medicine at different times. We will check how much medicine is in their blood and for any safety concerns or immune reactions. This type of study, called a bioequivalence study, helps ensure new, similar medicines are just as safe and effective as the original.
At a glance
What is this study about?
Imagine you have a well-known brand of medicine that works really well. Over time, other companies might want to make their own, similar versions once the original patent expires. These new, similar medicines are called 'biosimilars'. This study is all about one of these new biosimilar medicines, called MB04, which is designed to be very much like a medicine called Enbrel.
Enbrel is a powerful medicine often used to treat conditions where the body's immune system mistakenly attacks its own tissues, like in rheumatoid arthritis or psoriasis. The main goal of this study is to carefully compare MB04 with the original Enbrel – specifically, both the Enbrel sold in Europe and the Enbrel sold in the US. We want to be absolutely sure that MB04 behaves in the body in the same way as the original Enbrel.
By doing this, researchers can gather important information to show that MB04 is just as safe and effective as the original medicine. This process is crucial because it means that eventually, more people might have access to similar effective treatments, potentially at a lower cost, while still maintaining high standards of safety and quality.
Key takeaways
- This study compares a new medicine (MB04) to an existing one (Enbrel).
- It aims to confirm the new medicine works just like the original.
- Only healthy men aged 18 and over can take part.
- Participants will receive doses of different medicines over time.
- Safety and how the body handles the medicine are the main things being checked.
- This research helps make new, similar medicines available safely.
Who may be eligible?
This study is looking for volunteers who are healthy men. You must be at least 18 years old to take part; there is no upper age limit, as long as you are healthy enough for the study.
To be considered healthy, doctors will check you carefully using various tests, like blood tests, and ask about your medical history. This is to make sure that nothing in your health might affect how the medicine works or put you at unnecessary risk.
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 a man?
- Are you 18 years old or older?
- Do you consider yourself generally healthy?
- Do you not have any known long-term health conditions?
- Will you be able to attend several clinic visits?
What does participation involve?
If you decide to take part, you will be given a single dose of the study medicines over three different occasions, with a break in between each to allow the previous medicine to leave your system. This is a "crossover" study, meaning you will receive each type of medicine at a different time.
Throughout the study, nurses and doctors will monitor your health closely. This will involve regular blood samples to see how the medicine moves through your body and how long it stays there. They will also check for any side effects or changes in your immune system. You will have several clinic visits for these checks and to receive the medication. The total duration of your participation will depend on how long it takes for the medicine to clear your system between doses and for all the follow-up checks.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is a biosimilar medicine?
A biosimilar medicine is a new version of an existing biological medicine, very much like a copy, but made by a different company. It's designed to work in the same way as the original medicine.
Why is this study only for healthy men?
Studies like this often start with healthy volunteers who don't have other health conditions, so researchers can clearly see how the medicine acts in the body without other illnesses interfering with the results.
Will I know which medicine I'm getting?
No, this is a "double-blind" study, meaning neither you nor the study team will know which specific medicine (MB04, European Enbrel, or US Enbrel) you are receiving at any given time. This helps ensure fair and unbiased results.
What does 'pharmacokinetics' mean?
Pharmacokinetics is a scientific term that just means how your body handles a medicine – how it absorbs it, distributes it, breaks it down, and removes it.
What happens if I feel unwell during the study?
Your safety is the top priority. The study team will monitor you closely, and you should always report any new or unusual feelings or symptoms to them immediately. Medical help will always be available.
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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