Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Investigate the Effect of RO7504109 on Immune Cells in Healthy Participants

This research is an early-stage study, often called a Phase I trial. We are investigating a new medicine, known as RO7504109, to understand how it interacts with the body. Specifically, we're looking at its effects on your immune cells, which are a vital part of your body's natural defence system against illness. For this study, we're inviting healthy adults aged 18 and over, both men and women, to participate. The main goal is to check the medicine's safety and how it behaves in the human body, not to treat any specific condition. This kind of research is very important for developing new treatments in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

16 Sep 2025

Not Applicable (N/A)

What is this study about?

Imagine your body has its own special army that fights off germs and keeps you healthy – these are your immune cells. Researchers are working on a new medicine called RO7504109, and this study aims to understand how this medicine might affect these important immune cells.

This is a very early step in testing the medicine, often called a 'Phase I' study. At this stage, the main goal isn't to treat a specific illness, but rather to carefully check if the medicine is safe for people and to see how the body handles it. This involves looking closely at how the medicine moves through your system and what it does to your immune cells.

By taking part, you would be helping scientists learn more about this potential new medicine. The information gathered from healthy volunteers like you is crucial for deciding if the medicine can be studied further in people who might have certain health conditions in the future. It's a key part of developing new ways to help people stay healthy.

Key takeaways

This is an early-stage study of a new medicine called RO7504109.
The main goal is to check its safety and how it affects immune cells in healthy people.
Participation involves clinic visits, taking the study medicine, and regular health checks.
Volunteers must be healthy adults aged 18 or over.
Your contribution helps advance important medical research.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, we're looking for healthy adults. This means you should generally be feeling well and not have any ongoing serious health problems.

Both men and women are welcome to participate. You must be at least 18 years old, and there's no upper age limit, meaning older adults can also take part if they meet all the other health requirements.

The research team will carry out several checks, including health assessments and medical history reviews, to be sure this study is right for you and that you meet all the specific criteria. It's important for your safety and the accuracy of the study results.

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 generally healthy and feel well?
Are you at least 18 years old?
Are you available for multiple clinic visits?
Are you willing to take a new, untried medicine?
Do you understand that there are no direct personal health benefits?
Are you comfortable with regular health checks like blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several visits to a clinic over a period of time. You would be given the study medicine, RO7504109, and the doctors would carefully monitor how your body reacts.

During these visits, you can expect to have various assessments, which might include blood tests, urine tests, and physical examinations to check your overall health and see how the medicine is affecting your immune cells. You'll also be asked about any feelings or changes you notice after taking the medicine.

There will be follow-up appointments after you've finished taking the medicine to make sure you're doing well. The total duration of your participation, from your first visit to your final follow-up, will be explained in detail by the study team, but typically early-stage studies can last several weeks to a few months.

Potential risks and benefits

While there are no direct health benefits to you for taking part in this study, the information learned will help scientists understand more about this new medicine and could benefit others in the future. As with any medicine, there's always a chance of side effects, which could be mild, like a headache, or more serious, though rare. All known and potential risks will be thoroughly explained to you, and you will be closely monitored. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Netherlands

Common questions

What is RO7504109?

RO7504109 is a new medicine being developed. This study is an early step to understand how it works and if it's safe for people.

Why are you looking for healthy people?

We test new medicines on healthy volunteers first to understand how they affect the body without the complications of an existing illness. This helps us ensure it's safe before trying it in people who might be unwell.

Will I get paid for taking part?

It's common for studies like this to offer some payment for your time, travel, and inconvenience. Specific details will be provided by the study team.

What's an 'immune cell'?

Immune cells are special cells in your body that help fight off infections, viruses, and other harmful things to keep you healthy.

What if I change my mind after joining?

You are free to leave the study at any time, for any reason, without needing to explain why. It will not affect your future medical care.