AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Study to See How a New Compound, Trontinemab Affects the Body and Whether Immune Signals Triggered by it Affect How Other Medicines are Processed

This is an early-stage (Phase 1) clinical trial testing an experimental medicine called trontinemab. The main goal is to find out what happens to the drug once it enters the body and how the body handles it. Sometimes, when a new medicine triggers an immune reaction, the body produces chemical signals. Researchers want to know whether these signals change how the liver and body process other standard medicines. Understanding this helps doctors know if trontinemab can be safely taken alongside other treatments in the future. The trial is open to adult men aged 18 and older. Because this is an early safety study, participants will be monitored very closely by a team of doctors and nurses throughout their time on the trial.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

F. Hoffmann-La Roche AG

Enrolment target

Start

04 Sep 2026

Not Applicable

What is this study about?

When scientists create a new medicine, they must carefully test it in people to make sure it is safe. This study is looking at an experimental drug called trontinemab. It is a 'Phase 1' study, which means it is one of the very first times the medicine is being tested in humans to see how the body absorbs, breaks down, and clears it.

Another important part of this trial is looking at how medicines interact with each other. Sometimes, a new medicine can cause the immune system to release natural chemical messengers. In some cases, these messengers can speed up or slow down how the body handles other medicines, such as blood pressure pills or painkillers. Researchers want to see if trontinemab causes any of these changes.

By testing this early, doctors can understand whether people who take trontinemab in the future need adjusted doses of their other everyday prescriptions. This helps ensure that future treatments using this drug are as safe and effective as possible.

Key takeaways

The trial tests an experimental medicine called trontinemab in adult men.
Researchers want to see how the body processes the drug and if it affects other medicines.
This is an early-stage Phase 1 study focused primarily on safety and pharmacology.
Participants will be closely looked after and monitored with regular tests.
Joining is entirely voluntary, and you can withdraw at any time.

Who may be eligible?

This trial is looking for men aged 18 and older. At this early stage of research, the study team has set specific criteria to make sure the trial is as safe as possible for everyone taking part.

Because this is an early pharmacology study, participants will usually need to undergo detailed health checks before joining. These checks make sure it is safe for you to receive the study drug and that your organs, like your heart, liver, and kidneys, are working well.

The trial team will check any medicines you currently take, your medical history, and your lifestyle habits to decide if this study is suitable for you.

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 a man aged 18 or older.
I am willing to attend regular clinic appointments or stay overnight if required.
I am happy to have routine health checks, including blood tests and heart traces.
I can follow trial guidelines, such as using reliable contraception if needed.
I am open to discussing my full medical history and current medicines with the research team.

Answer every question to see your result.

What does participation involve?

Taking part in this study begins with a screening visit, where the team will check your overall health using routine tests like blood samples, urine tests, and heart traces (ECGs). If you can join, you will be given the study drug trontinemab under close medical supervision. You may need to stay at a dedicated research clinic for a short period or attend several day visits so the team can take regular blood samples to measure drug levels. After you finish receiving the medicine, you will have follow-up visits or phone calls to check on your recovery and general wellbeing.

Potential risks and benefits

Because this is an early-stage study, you are unlikely to receive any direct health benefit from taking part, though your participation helps scientists develop safe medicines for others. There are potential risks, including unexpected side effects, allergic reactions, or discomfort from regular blood tests. The medical team will monitor you closely to manage any issues quickly. Taking part is completely your choice, and you are free to leave the study at any time without giving a reason and without it affecting your regular NHS 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
Germany

Common questions

What is a Phase 1 study?

A Phase 1 study is an early stage of clinical research. Its main purpose is to test the safety of a new medicine, see how the body handles it, and check for any side effects.

Why is this study only open to men?

Early safety trials often test medicines in specific groups first to keep the study design simple and avoid potential risks to reproductive health while safety data is still being gathered.

Will I be paid for taking part?

Many early-stage trials offer payment to cover your time and travel expenses. The study team can give you full details about any payments during your screening.

What are immune signals?

Immune signals are natural chemical messengers your body makes when fighting things off or reacting to treatments. Sometimes they can temporarily alter how the liver processes other drugs.

Can I leave the trial if I change my mind?

Yes. Taking part is completely voluntary. You can stop participating at any point, and your normal healthcare will not be affected in any way.