Phase 1 Safety and Tolerability Study of ALN-F1202 in Healthy Adults.
This clinical research trial is testing a new experimental medicine named ALN-F1202. It is a Phase 1 study, meaning it is the very first time the medicine is being given to people. Before any new treatment can be used to treat diseases, scientists must first check that it is safe in healthy individuals. The main aim is to understand how the body processes ALN-F1202 and to look out for any side effects. Doctors will monitor volunteers very carefully throughout the study using routine checks like blood tests and heart scans. Because this is an early safety trial, researchers are looking for healthy adult volunteers aged 18 and older. Taking part will not treat any medical condition you may have, but it helps doctors decide whether this medicine could safely help patients in future studies.
At a glance
What is this study about?
Every new medicine must go through careful testing before it can be used in clinics or hospitals. This study is testing a drug called ALN-F1202. It is what doctors call a 'first-in-human' Phase 1 trial. This means the medicine has shown promise in laboratory tests, and researchers are now ready to take the very first step of testing it safely in people.
In this trial, the drug is given to healthy volunteers rather than people with a specific medical condition. This is important because it allows the research team to see exactly how the medicine behaves in a healthy body, without the effects of an underlying illness or other medications getting in the way. They will check how the medicine is absorbed, broken down, and removed by the body.
Throughout the study, medical staff will watch participants very closely to see how well they tolerate the medicine. The findings from this trial will help scientists understand the right doses to use and help ensure that any future trials in patients are as safe as possible.
Key takeaways
- Tests an experimental drug called ALN-F1202 for the first time in people.
- Aimed at checking the drug's safety, side effects, and how the body breaks it down.
- Open to healthy adult volunteers aged 18 and older.
- Does not treat any disease or provide personal medical benefit.
- Participants will be closely watched by medical staff throughout the study.
Who may be eligible?
This trial is open to adults aged 18 and over of any sex. Because the purpose of the study is to test baseline safety, participants must generally be in good overall health.
To be considered healthy for this type of trial, you typically need to have normal results on health screenings. This includes normal blood pressure, a healthy heart rhythm, and good blood test results. You should usually not have any long-term or serious medical conditions.
You may not be eligible if you take certain regular prescription medications, smoke heavily, use recreational drugs, or if you are pregnant or breastfeeding. The study team will review your full medical history during a screening visit to make sure it is safe for you to take part.
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 major long-term illnesses or heart conditions.
- I am not currently pregnant or breastfeeding.
- I am willing to attend clinic appointments and have routine health checks.
What does participation involve?
Taking part usually begins with a thorough screening visit where doctors will review your medical history and run tests such as blood samples, urine tests, and an electrocardiogram (ECG) to check your heart. If you are eligible, you will be given the study medicine, ALN-F1202. Depending on the trial plan, this may involve an overnight stay at a research clinic or several day visits so the medical team can watch for any reactions. You will have regular checks to monitor your vital signs and see how the medicine moves through your system. After taking the dose, you will have follow-up visits or telephone calls over several weeks or months so the team can confirm you remain well.
Potential risks and benefits
Locations (1)
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Common questions
What does a Phase 1 trial mean?
A Phase 1 trial is the earliest stage of testing in humans. Its main purpose is to test safety, find side effects, and see how the body handles the medicine.
Will taking part improve my health?
No. Because this trial is designed only to test safety in healthy people, you will not receive any direct medical benefit from the medicine.
Will I be paid for taking part?
Phase 1 trials with healthy volunteers usually offer financial compensation to cover your time, travel expenses, and inconvenience.
What happens if I experience side effects?
A team of doctors and nurses will monitor you very closely. If you feel unwell, they will provide immediate medical care and advice.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary. You can withdraw your consent and leave the study at any time.
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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