RecruitingPHASE1INTERVENTIONAL

A Study to Evaluate ALN-4285 in Adult Healthy Volunteers

This research study is testing a new medication called ALN-4285. Its main goals are to check how safe it is and if healthy people can handle it well when given different single doses. Researchers also want to understand how the body processes this medication, including how it's absorbed and removed. To achieve this, some participants will receive ALN-4285, while others will be given a placebo, which is an inactive substance that looks just like the real medication. This is a common way to accurately compare the effects of the new treatment.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Alnylam Pharmaceuticals

Enrolment target

Start

12 Dec 2025

Estimated completion

23 Mar 2027

Healthy Volunteers

What is this study about?

This study is about a new investigational medication called ALN-4285. When a new medication 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 an early-stage trial, which means it's one of the first times this medication has been given to people.

The main purpose of this research is twofold: firstly, to check how safe ALN-4285 is and if healthy volunteers can tolerate it without serious side effects, especially when given in different single doses. Secondly, the study aims to understand how the body handles ALN-4285 – this includes how it's absorbed, distributed, broken down, and eventually removed from the body. This information is vital for future studies to figure out the best doses and how often the medication might need to be taken.

Participants in this study will either receive ALN-4285 or a placebo. A placebo looks exactly like the actual medication but doesn't contain any active ingredients. Using a placebo helps researchers compare the effects of the new medication against no treatment at all, ensuring that any changes observed are truly due to ALN-4285 and not other factors. Studies like this are a crucial step in bringing new, potentially life-changing medications to patients in the future.

Key takeaways

This is an early-stage study testing a new medication called ALN-4285.
The main goals are to check its safety, how well people can tolerate it, and how the body handles it.
Participants will be healthy adults aged 18 to 65 years.
You will either receive the study medication or a dummy treatment (placebo).
Taking part helps advance medical research, but there may be no direct personal health benefit.
You can withdraw from the study at any time without needing a reason.

Who may be eligible?

To join this study, volunteers must be between 18 and 65 years old. Your body mass index (BMI), which is a measure of your weight in relation to your height, needs to be within a certain range (not too low, not too high).

Before you can take part, doctors will perform some checks to make sure you're healthy enough. This includes having a normal heart tracing (ECG) and healthy blood pressure. Your liver and kidney function will also be checked with blood tests to ensure they are working well.

You would not be able to join if you have certain health conditions, or if your blood tests show signs of liver or kidney problems. Also, if you've taken part in another research study or received another investigational medication recently (within the last month or so), you might not be eligible.

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 between 18 and 65 years old?
Is your BMI (body weight relative to height) within the healthy range specified by the study team?
Do you generally feel healthy and well?
Have you not taken part in another drug study or received an experimental treatment recently?
Do you have normal heart and kidney function, and healthy blood pressure?
Are your liver function blood test results normal?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have several visits to the study clinic. During these visits, the study team will carry out various health checks, including blood pressure readings, heart tracings (ECGs), and blood and urine samples. You will be given either the study medication (ALN-4285) or a placebo, which looks the same but contains no active drug. You won't know which one you're receiving.

After you take the medication, you will be closely monitored for a period to see how your body reacts and to collect samples. There might also be follow-up phone calls or visits to check on your well-being. The total length of your participation, including all visits and follow-ups, will be clearly explained to you before you agree to join.

Potential risks and benefits

Taking part in a study like this might not directly benefit your health, as it's an early-stage trial focused on safety. However, it helps advance medical knowledge and could contribute to developing new treatments for others in the future. Potential risks could include side effects from the medication, discomfort from blood tests, or inconvenience from the study visits. All potential risks will be thoroughly explained, and you always have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Clinical Trial Site
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is ALN-4285?

ALN-4285 is a new medication that is currently being tested in research studies. It has not yet been approved for general use.

Why are healthy volunteers needed?

Healthy volunteers help researchers understand how new medications affect the body when there are no other health conditions involved. This helps to check its safety and how it works before testing it in patients with a specific illness.

Will I know if I'm getting the real medication or the placebo?

No, during the study, neither you nor the study team will know if you are receiving ALN-4285 or the placebo. This is to ensure the results are as accurate and unbiased as possible.

What happens if I experience side effects?

The study team will closely monitor you for any side effects. If you experience any, you should report them immediately. They will provide appropriate medical care and guidance.

Do I get paid for taking part?

Information about payment or compensation for your time and travel will be provided to you during the initial discussions about the study.

How to find out more

Clinical Trial Information Line

clinicaltrials@alnylam.com 1-877-ALNYLAM Official trial record

Always speak to your GP or specialist before deciding to take part in a study.