A study to evaluate the safety and tolerability of single ascending doses of AGMB-101 in healthy participants (Part A) and patients with liver cirrhosis (Part B).
This research is testing a new medicine called AGMB-101. The main aim is to understand if it's safe to use and how people react to different amounts of it. The study is divided into two main parts. In the first part, healthy people will be given a single dose of the medicine, and the dose will gradually be increased for different groups to see how they respond. In the second part, people who have liver cirrhosis, a type of long-term liver damage, will also receive the medicine. This is a very early stage of human testing, often called 'Phase 1', where careful checks are made on how the body handles the new medicine. The information gathered will help decide if it's safe to continue testing AGMB-101 in future, larger studies.
At a glance
What is this study about?
This study is focused on a new medicine called AGMB-101. When a new medicine is developed, it goes through several stages of testing to make sure it's safe and effective before it can be used widely. This particular study is one of the very first stages of testing in humans. It's sometimes called 'Phase 1' or 'Human Pharmacology'.
The main goal of this early study is to find out if AGMB-101 is safe for people and how well their bodies tolerate it. This means looking for any unwanted reactions or side effects when different amounts of the medicine are given. They also want to see how the medicine behaves in the body, for example, how it's absorbed, changed, and removed.
To do this, the study is split into two parts. In the first part, healthy volunteers will receive the medicine. This helps researchers understand how the medicine affects a body that isn't already dealing with an illness. In the second part, people who have liver cirrhosis will be given the medicine. Liver cirrhosis is a serious long-term condition where the liver is scarred and doesn't work as well as it should. By studying both healthy people and those with liver cirrhosis, researchers can learn more about how the medicine might work and if it's safe for people with this specific health condition. This information is crucial for deciding if the medicine should continue to be developed and tested in larger studies.
Key takeaways
- This is an early study of a new medicine for liver conditions.
- It aims to check the safety and how people tolerate the medicine, AGMB-101.
- Healthy volunteers and people with liver cirrhosis will take part.
- Participants will receive a single dose and be carefully monitored.
- Your involvement could help future research into liver disease.
Who may be eligible?
To be able to take part in this study, you would generally need to be an adult, aged 18 or older. There is no upper age limit mentioned.
Both men and women are welcome to participate. The study is particularly looking for two groups of people: healthy volunteers for the first part of the study, and people who have been diagnosed with liver cirrhosis for the second part.
Keep in mind that while these are the basic requirements, there will be other specific health checks and criteria that a study doctor will need to review to make sure it's safe for you to take part. This ensures the study is conducted safely and gathers the most useful information.
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.
- Am I 18 years old or older?
- Do I have liver cirrhosis (if applying for Part B)?
- Am I generally healthy (if applying for Part A)?
- Am I able to attend several appointments and follow study instructions?
- Do I understand that I might not directly benefit from taking part?
What does participation involve?
If you decide to take part in this study, you would likely have several visits to a clinic or hospital. These visits would include a medical examination, blood tests, and other health checks to make sure you are suitable and stay well throughout the study. You would receive the study medicine, AGMB-101, usually as a single dose. After receiving the medicine, you would be carefully watched by the study team for a period to see how your body reacts and to monitor any side effects. You might need to stay overnight or for a certain number of hours at the clinic for observation. There will also be follow-up appointments to continue monitoring your health and the effects of the medicine. The total time you would be involved in the study, from your first screening visit to your last follow-up, would be fully explained to you before you agree to take part.
Potential risks and benefits
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Common questions
What is liver cirrhosis?
Liver cirrhosis is a serious condition where your liver is badly scarred and damaged, making it harder for it to work properly. Many things can cause it, like long-term alcohol use or certain liver diseases.
What does 'Phase 1' mean for a study?
Phase 1 is the very first step of testing a new medicine in people. It mainly focuses on whether the medicine is safe and how the body handles it, rather than if it cures a disease.
Will I get paid to be in the study?
Often, studies like this offer some payment for your time and travel, especially for healthy volunteers. This would be explained in detail before you agree to take part.
Will I know if I'm getting the real medicine or a dummy pill?
In this specific study, everyone receives the active medicine, AGMB-101. There isn't typically a dummy pill (placebo) part in this very early safety testing of single doses.
What if I get side effects from the medicine?
The study team will carefully monitor you for any side effects. If you experience anything unusual, you should tell them immediately. They are there to look after your health.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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