CompletedPhase IInterventional

Phase I trial HMR code: 25-001

This study is an early-stage research project, known as a Phase 1 trial, and is seeking healthy volunteers to take part. In Phase 1 trials, researchers typically test a new medicine or treatment for the very first time in people. The main goals are usually to see if it's safe, how much of it can be given, and how the body handles it. All the detailed information about what is being tested and why it matters will be made public within 30 months after the study has finished. For now, we know it's a foundational step to understand a potential new treatment.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Dr Falk Pharma GmbH

Enrolment target

Start

03 Jun 2025

Estimated completion

06 Apr 2026

Healthy volunteers

What is this study about?

This study is an early research project, often called a 'Phase 1' trial. Think of it as the very first step in testing a new medicine or treatment in people. When a new medicine is developed, it first goes through extensive testing in laboratories and then in animals. If those tests show promising results and indicate it might be safe enough for humans, it moves on to a Phase 1 trial.

In a trial like this, the main goals are usually to answer fundamental questions: Is the new treatment safe for people? What side effects might it have? How much of the treatment can be given safely? And how does the human body process it? Studies at this stage are crucial because they help scientists understand if a new medicine has the potential to be developed further.

The specific details about what exactly is being tested in this particular trial are not public yet. This is sometimes done to protect confidential information, especially in the early stages of development. However, the study organisers have confirmed that all the full details, including the exact aims and what's being investigated, will be shared and publicly available within 30 months after the study has concluded. This ensures transparency once key development stages have passed.

Key takeaways

This is an early-stage 'Phase 1' study looking for healthy volunteers.
The main aim is likely to check the safety of a new medicine or treatment.
Full details about the study will be made public within 30 months after it finishes.
Anyone of adult age (men and women) who is healthy can potentially take part.
Your involvement would help advance medical science for future patients.

Who may be eligible?

To be able to join this study, the main requirement is that you must be a healthy adult. This means you shouldn't have any significant ongoing health problems or illnesses that could affect the study results or put your health at risk during the trial.

At this stage, the specific reasons that might prevent someone from joining (called 'exclusion criteria') haven't been made public. Usually, these can include things like taking certain medications, having particular health conditions, or other factors that could interfere with how the new treatment works or how your body reacts to it.

Both men and women of any adult age are welcome to consider taking part, as long as they meet the 'healthy volunteer' requirement. More specific age limits, if any, will be part of the full details shared later.

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 considered a healthy person?
Do you currently have any significant long-term illnesses?
Are you taking any regular prescription medications?
Are you an adult (any age)?
Are you able to commit to potential clinic visits or stays?

Answer every question to see your result.

What does participation involve?

Since the full details of this study are not yet public, we can't give specific information about what taking part would involve. However, in most Phase 1 trials for healthy volunteers, you would likely have a screening visit to check your health thoroughly. If you qualify, you might need to stay at a clinic for a few days or come in for several shorter visits over a period of weeks or months. This could involve taking the study medication, having blood tests, urine tests, physical check-ups, and potentially heart monitoring (like an ECG). The total duration of your involvement could range from a few weeks to a few months, including any follow-up appointments.

Potential risks and benefits

Taking part in any medical study carries potential risks, as new treatments are being tested. For healthy volunteers, these usually relate to side effects from the study treatment, which could be mild or, in rare cases, more serious. However, studies are designed with participant safety as the top priority. The direct benefit to you as a healthy volunteer is usually not related to your health, but rather the knowledge that you are contributing to medical science, which could help future patients. 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.

Hammersmith Medicines Research (HMR)
City only
London, United Kingdom

Common questions

What does 'Phase I trial' mean?

It's usually the very first time a new medicine or treatment is tested in people to check its safety, side effects, and how the body handles it.

Why is it only looking for 'healthy volunteers'?

Researchers often start with healthy people to safely understand how a new treatment affects the body without other health conditions making it complicated.

What does 'deferral of publication' mean?

It means the detailed information about the study won't be made public immediately, but it will be shared within 30 months after the study ends.

Will I be paid to take part?

Often, healthy volunteers in Phase 1 trials receive some payment for their time and effort, but this isn't always the case and would be confirmed by the study team.

How long will the study last for me?

The full details aren't out yet, but typical Phase 1 studies for healthy volunteers can involve multiple visits or stays over a few weeks to a few months.

How to find out more

Ph1 Department

phase1@drfalkpharma.de +49 (0)76115140 Official trial record

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