A PHASE 1 TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PK, AND PD of AX-0810 IN HEALTHY PARTICIPANTS
This phase 1 clinical trial is the first time the study medicine, AX-0810, is being given to humans. It is designed for healthy adult volunteers, rather than people who are currently unwell. Researchers are testing AX-0810 to see how safe it is and whether it causes any unwanted side effects. They will also measure how the drug moves through the body, how long it stays in the blood, and what effects it has on body chemistry. Although healthy volunteers take part in this trial, the overall goal is to find a new treatment for cholestatic liver disease. This is a condition where digestive fluid called bile cannot flow properly from the liver, leading to liver damage. If AX-0810 proves safe in healthy people, future trials will test whether it can help protect the liver in patients with this condition.
At a glance
What is this study about?
This study is an early-stage clinical trial testing a new experimental medicine called AX-0810. Because this is a 'Phase 1' study, it is the very first time the drug is being tested in humans. Before a new drug can be given to patients who are ill, scientists must first carefully check how it behaves in healthy volunteers to make sure it is safe to use.
The long-term aim of this research is to find new ways to treat cholestatic liver diseases. The liver produces a digestive fluid called bile, which helps break down fats and clears waste from the body. In cholestatic liver diseases, the flow of bile slows down or becomes blocked. Over time, bile builds up inside the liver, causing inflammation, itching, tiredness, and lasting liver damage. Current treatments do not work for everyone, so new medicines are urgently needed.
In this trial, doctors will closely monitor volunteers after they take AX-0810. They will look at how the body absorbs, breaks down, and removes the drug, and check for any unexpected side effects. While taking part will not directly improve a volunteer's health, it provides vital information that could help doctors develop effective treatments for liver patients in the future.
Key takeaways
- This is a first-in-human trial testing the safety of a new drug called AX-0810.
- The study is for healthy adult volunteers aged 18 and over.
- The research aims to support the future development of treatments for cholestatic liver disease.
- Participants will be closely monitored with regular health checks and blood tests.
- Taking part is entirely voluntary, and you can leave the study at any time.
Who may be eligible?
This study is looking for healthy adult volunteers aged 18 and older. Both men and women are welcome to take part. Because this is a safety test, researchers need people who do not have any major ongoing medical conditions.
To be eligible, you will need to undergo medical checks to confirm that your heart, liver, kidneys, and other organs are functioning normally. You should generally not be taking regular prescription medicines, as these could interfere with the study results.
You will likely not be able to join if you have a history of serious illness, liver problems, or drug allergies. Women who are pregnant or breastfeeding are also excluded to protect their health and the safety of the baby. The study team will review your full medical history before you can join.
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.
- I am aged 18 or older.
- I consider myself to be in good general health.
- I do not have any known liver problems or serious chronic diseases.
- I am not currently pregnant or breastfeeding.
- I am willing to attend clinic visits and undergo regular blood tests.
What does participation involve?
Taking part in this study involves visiting a specialist clinical trial clinic. Before anything begins, the research team will explain the study in full and ask you to sign a consent form. You will have a thorough health check, which includes blood tests, urine tests, blood pressure checks, and heart traces (ECGs).
If you join, you will be given the study medicine, AX-0810. Depending on the exact study plan, you may need to stay at the clinic overnight or for a few days so the doctors can monitor you closely. Staff will take regular blood and urine samples over several hours or days to see how quickly your body clears the medicine.
After you receive the dose, you will have follow-up visits or phone calls to check that you are feeling well and that any side effects are recorded. The total time you spend in the trial typically ranges from a few weeks to a couple of months.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is a Phase 1 clinical trial?
A Phase 1 trial is the earliest stage of human testing. It focuses on finding out if a new drug is safe, what dose is best, and how the body handles it.
Do I need to have a liver condition to take part?
No. This trial specifically needs healthy volunteers to test the drug's safety before it is given to people who are unwell.
Will I be paid for taking part?
Phase 1 trials with healthy volunteers often provide payment to compensate you for your time, travel, and any inconvenience, but you should confirm this with the study clinic.
How is the study medicine taken?
The medicine is usually given either as a tablet to swallow or as an injection or drip. The trial team will explain the exact method before you agree to join.
What happens if I change my mind?
You can leave the trial at any time. You do not have to give a reason, and your normal healthcare will not be affected in any way.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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