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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Randomized, Open Label, Single-Dose Crossover Study to Assess the Relative Bioavailability, Food Effect, and Safety of Capsule Formulations of INF904.

This study is an early-stage research project designed to learn more about a new medicine called INF904. We're testing different ways of giving this medicine, specifically capsule forms, to see how well they are absorbed into the body. We also want to find out if eating food affects how the medicine works. This study involves healthy adult volunteers and is mainly focused on understanding how the medicine behaves in the body and checking for any early safety concerns. It’s an important step before testing the medicine in people with specific illnesses. Your participation helps us gather vital information to develop new treatments.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
InflaRx GmbH
Enrolment target
51
Start
13 Jun 2024

What is this study about?

Imagine a new medicine is like a new car, and before it can be driven on public roads, we need to test it thoroughly. This study is one of the very first tests for a new medicine called INF904. Our main goal is to understand how this medicine behaves inside the human body. We'll be looking at different forms of the medicine, specifically capsules, to see how well they are absorbed and delivered to where they need to go. Think of it like comparing different fuel types for our car – does one make it run better or get to its destination faster?

Another important part of this study is to see if eating food at the same time as taking the medicine changes how it's absorbed. Sometimes food can stop a medicine from working properly, or it can even help it. By understanding this, doctors will know the best way to advise patients to take the medicine in the future.

This type of study is called a 'Phase 1' study. It's one of the earliest steps in developing a new medicine and mainly involves healthy volunteers. The main aims are to check if the medicine is safe and how the body handles it. The information we gather is really important and helps us decide if the medicine is promising enough to continue testing in larger studies with people who have the condition the medicine is designed to treat.

Key takeaways

  • This is an early study for a new medicine called INF904.
  • It's for healthy adult volunteers.
  • The main goals are to check how the medicine is absorbed and if food affects it.
  • It's important for understanding the medicine's safety and how it works in the body.
  • Participants will receive different forms of the medicine and have regular health checks.

Who may be eligible?

This study is looking for healthy adults to take part. This means we're looking for individuals who don't have any major ongoing health conditions. We want to understand how the medicine works in typical, healthy people before testing it in those with particular illnesses.

To be eligible, you need to be at least 18 years old. There is no upper age limit mentioned, but other health checks might be done to ensure you're in good general health. Both men and women are welcome to participate in this research.

Before you can join, a doctor or nurse will check your health carefully to make sure the study is a safe and good fit for you. This often involves discussions about your health history, a physical examination, and some blood tests.

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.

  1. Are you 18 years old or older?
  2. Are you generally in good health?
  3. Are you able to visit the study clinic multiple times?
  4. Are you willing to have blood samples taken regularly?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive different forms of the medicine, INF904, at various times. This is called a 'crossover' study, meaning you'll get each different form at different times, so we can compare them directly in the same person. You would likely need to visit the study clinic multiple times, and these visits might include overnight stays or several hours at the clinic. During these visits, nurses and doctors would regularly take blood samples to measure how much of the medicine is in your body. They would also monitor your vital signs, like blood pressure and heart rate, and ask you about how you are feeling to check for any side effects. You would also have specific instructions about when and what to eat, especially around the times you take the medicine, as we are studying the effect of food. The total duration of your participation, including all visits and follow-up, would be fully explained to you before you agree to join.

Potential risks and benefits

Potential benefits of taking part in this study include contributing to medical science and helping to develop new medicines that could help many people in the future. You will also receive careful medical monitoring during your participation. Potential risks could include side effects from the medicine, which will be fully explained to you, as well as discomfort from regular blood tests. All medicines have potential risks, even those in early development, and these will be discussed in detail. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

Common questions

What is INF904?

INF904 is a new medicine that is being investigated. This study is an early step to understand how it works in the body and if it's safe.

Why do you need healthy volunteers?

We enrol healthy volunteers in early studies to understand how the medicine behaves in people without existing health conditions before testing it in those with specific illnesses.

Will I get the actual medicine or a dummy pill?

In this study, you will receive different types of the active medicine, INF904, in capsule form, at different times. There isn't a dummy pill (placebo) used for comparison in this specific study.

Will I be paid for taking part?

The study team will be able to tell you if there is any payment or compensation for your time and travel if you decide to take part.

How long will the study last for me?

The total length of your participation, including all visits and follow-up, would be fully explained by the study team before you agree to join.

How to find out more

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

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