AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Food effect and single- and multiple-ascending dose clinical trial of DF2755A in healthy participants

This clinical trial is designed to understand a new medicine, DF2755A, that could potentially help people with interstitial cystitis or bladder pain syndrome. The study is in its very first stage and involves healthy adult volunteers. Researchers want to see how the new medicine is absorbed, processed, and removed by the body, both with and without food. They will also look at how different doses affect the body. This helps them find a safe and effective dose before testing it in patients with the condition. By studying healthy people, they can learn important information about the medicine's basic properties and how it might work, paving the way for future studies.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Dompe' Farmaceutici S.p.A.

Enrolment target

Start

17 Oct 2025

interstitial cystitis/bladder pain syndrome

What is this study about?

This study is a very early step in researching a new medicine called DF2755A. It's intended for a condition called interstitial cystitis, also known as bladder pain syndrome, which causes ongoing bladder pain and discomfort. Before a new medicine can be given to people with a condition, it's usually first tested in healthy volunteers to understand how it works in the human body. This allows researchers to gather important information safely.

The main goals of this study are to see how the medicine is absorbed, broken down, and leaves the body. Researchers will look at how taking the medicine with food might change these processes. They will also give different amounts (doses) of the medicine to volunteers to see how the body reacts. This helps them figure out what doses are safe and how the medicine behaves at different levels.

Understanding these basic properties in healthy people is crucial. It helps scientists decide if the medicine is promising enough to move on to later stages of research, where it would then be tested in people who actually have interstitial cystitis or bladder pain syndrome. This careful, step-by-step approach ensures that potential new treatments are developed as safely and effectively as possible.

Key takeaways

This is an early-stage study (Phase I) of a new medicine, DF2755A.
It aims to understand how the medicine behaves in healthy adults.
Researchers are looking at safety, how food affects it, and different dose levels.
The ultimate goal is to find new treatments for bladder pain syndrome.
Participation involves taking the medicine, clinic visits, and monitoring.
You contribute to future medical knowledge, but risks of new medicine exist.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. Both men and women are welcome to take part. Since this is an early study of a new medicine, they are looking for healthy people who don't have existing medical conditions that might affect how the medicine works or lead to other health concerns during the trial.

Being healthy means you generally don't have any major ongoing illnesses or take regular medications that could interfere with the study drug. The research team will do medical checks to make sure you're suitable. They will also look at your medical history to ensure your safety throughout the study.

Specific details about who can or cannot join will be discussed thoroughly with you by the study team if you express interest. This ensures that the study is safe for everyone involved and that the results are clear.

Quick self-check

Are you 18 years old or older?
Are you generally considered a healthy adult?
Are you comfortable with taking a new, experimental medicine?
Are you able to attend several clinic visits, potentially including overnight stays?
Are you willing to have blood and urine samples taken regularly?
Do you understand this is an early-stage study with unknown effects?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive the new investigational medicine, DF2755A. This is a very early stage of research, so it involves careful monitoring. You would have several visits to the study clinic, and during these visits, the research team would collect blood and urine samples and perform various health checks such as measuring your blood pressure and heart rate. You might also be asked to stay overnight at the clinic for certain periods. The study involves taking the medicine and then being observed to see how your body reacts to it, including how it's affected by food. The total length of your involvement in the study will be explained in detail by the research team.

Potential risks and benefits

Participating in research always carries potential benefits and risks. One potential benefit is that you would be contributing to medical science, which could help develop new treatments for bladder pain syndrome in the future. However, because this is a new medicine, there might be side effects that are not yet fully known. These could range from mild discomforts to more serious reactions, though every precaution is taken to ensure your safety. You will be closely monitored by medical professionals throughout the study. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

—
Netherlands

Common questions

What is interstitial cystitis/bladder pain syndrome?

It's a long-term condition that causes ongoing pain and discomfort in the bladder and pelvic area. The exact cause isn't fully understood, and current treatments aim to manage the symptoms.

Why is this study using healthy volunteers?

Testing new medicines in healthy volunteers first is a standard and important step. It helps researchers safely understand how the medicine works in the body and find a safe dose before it's given to people who have the condition.

What does 'single- and multiple-ascending dose' mean?

It means some volunteers will take a single dose, and others will take the medicine multiple times. 'Ascending dose' means different groups will receive gradually increasing amounts of the medicine, allowing researchers to see how the body handles different quantities.

What does 'food effect' mean in this study?

The researchers want to find out if taking the medicine with food changes how much of it gets into your bloodstream and how fast. This helps determine the best way for patients to take the medicine in the future.

Is DF2755A a proven medicine for bladder pain?

No, DF2755A is a new investigational medicine, meaning it's still being researched and is not yet approved for treating any condition. This study is an early step in finding out if it could be a useful treatment in the future.