A randomized, placebo-controlled, double-blind, single-ascending-dose, Phase 1a/b study to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of intravenous NTR-641 in healthy adults and patients with acute ischemic stroke
This research is looking into a new medicine, NTR-641, for people who have recently experienced an acute ischemic stroke. This type of stroke happens when a blood clot blocks blood flow to the brain. The study will first give small doses of NTR-641 to healthy adults to make sure it's safe. After that, it will be given to a small number of stroke patients. Researchers will carefully check for any side effects and how the body handles the medicine. They also want to understand how it works and if the body's immune system reacts to it. The main goal is to see if NTR-641 could be a helpful new treatment option for stroke patients in the future.
At a glance
What is this study about?
This study is about a new medicine called NTR-641. We're investigating it to see if it could help people who have had an acute ischemic stroke. An acute ischemic stroke happens suddenly when a blood clot blocks an artery, stopping blood flow to a part of the brain. This can cause serious damage.
The main purpose of this study is to find out if NTR-641 is safe for people. We also want to understand how it moves through your body after you take it, how long it stays there, and how your body reacts to it generally. This is the very first time this medicine is being given to people, so we're starting carefully.
First, a small number of healthy adult volunteers will receive a dose of NTR-641. This helps us check its safety and how it behaves in the body when there’s no immediate health issue. If these first steps show it’s safe, a small group of patients who have recently had an acute ischemic stroke will then receive a dose. This helps us see if it's safe for people with this condition and if it works as we hope, paving the way for larger studies in the future if it looks promising.
Key takeaways
- Tests a new medicine (NTR-641) for acute ischemic stroke.
- First checks safety in healthy adults.
- Then aims to understand safety and effects in stroke patients.
- It's a very early stage (Phase 1) study.
- Participation helps future stroke treatments.
- Neither you nor the doctors know if you get the real medicine.
Who may be eligible?
This study is looking for both healthy adults and people who have recently had a specific type of stroke. To take part, you need to be at least 18 years old, and there is no upper age limit for joining.
Whether you are male or female, you can be considered for this study. The researchers will have a set of specific health requirements and other conditions that you would need to meet to be eligible. These are put in place to ensure your safety and that the study results are clear.
It's important to remember that not everyone who is interested will be able to join. The research team will review your medical history and conduct some tests to see if this study is the right fit for you. They will explain all the details.
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 18 years old or older?
- Do you (or someone you know) have an acute ischemic stroke, or are you a healthy adult?
- Are you comfortable with receiving medicine through an IV drip?
- Are you able to attend several follow-up visits?
- Are you willing to have regular blood tests and medical checks?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit where doctors check your health to make sure the study is suitable for you. If you pass this, you would receive the study medicine, NTR-641, through a drip into your arm (intravenous). This is done in a controlled medical setting. You would then have several follow-up visits, which could include examinations, blood tests, and other procedures to see how your body reacts to the medicine.
For the healthy volunteers, this might involve staying in the clinic for a short period. For stroke patients, the visits would be carefully scheduled around your ongoing care. The total time you would be involved in the study could vary, but the research team will explain the full schedule of visits and tests during the consent process.
Potential risks and benefits
Locations (1)
- —UnverifiedAustria
Common questions
What is an acute ischemic stroke?
It's a type of stroke caused by a blood clot blocking blood flow to your brain.
Is this medicine approved for stroke treatment?
No, NTR-641 is a new medicine and is currently only being tested in this research study. It is not yet approved as a treatment.
Will I know if I'm getting the real medicine or a dummy medicine?
No, this study is 'double-blind,' meaning neither you nor the study doctors will know who is receiving the new medicine and who is receiving a placebo (dummy medicine).
How will the medicine be given?
The medicine will be given directly into your bloodstream through a drip in your arm.
How long will I need to be in the study?
The total length of time you'd be involved will depend on the study group you're in. The research team will give you a detailed schedule.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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