Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A research study looking at how different doses of study medicine (Inno8) works in the body of healthy men.

This research study is looking at a new medicine called Inno8. It's an early-stage study, which means it's one of the first times this medicine is being given to people, in this case, healthy men. The main goal is to understand how Inno8 moves through the body, how much stays in the system, and how the body handles different doses. This information is key for future studies to make sure the medicine is safe and effective. While this specific trial is in healthy men, Inno8 is being developed to help people with haemophilia A, a condition where blood doesn't clot properly.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novo Nordisk A/S

Enrolment target

108

Start

16 Sep 2024

Prophylaxis and on-demand treatment respectively in patients with haemophilia A with or without FVIII inhibitors.

What is this study about?

This research study is about a new medicine called Inno8. Doctors want to understand how this medicine works inside the human body. Think of it like learning how a new car engine runs – they need to see how much fuel it uses, how fast it goes, and how it handles different speeds. In this study, they're giving different amounts (doses) of Inno8 to healthy men and carefully watching what happens.

This is a very early stage of testing for the medicine, often called a Phase I study. It's one of the first times Inno8 is being given to people, so the focus is mainly on safety and understanding how the body reacts to it. They'll be looking at things like how the medicine is absorbed, how it travels through the body, and how long it stays in the system.

Why is this important? The information gathered from this study, even though it's in healthy volunteers, is crucial for developing Inno8 further. Inno8 is being developed as a potential treatment for haemophilia A, a condition where a person's blood doesn't clot properly. By understanding how Inno8 behaves, researchers can decide on the best doses and design future studies to see if it can effectively help people with haemophilia A.

Key takeaways

Tests a new medicine, Inno8, in healthy men.
A very early-stage study (Phase I).
Aims to understand how the body handles the medicine.
Helps pave the way for future haemophilia A treatments.
Strictly for adult men, aged 18 and over.

Who may be eligible?

This study is specifically looking for volunteers who are adult men. You need to be at least 18 years old to take part, and there's no upper age limit, as long as you're healthy.

Because this is a very early study to understand how the medicine works in the body, it's designed for people who are generally well. You won't be able to join if you have any serious health conditions or are taking certain medications that might affect how Inno8 works or your safety during the study.

Don't worry if you're not sure if you qualify. The research team will do a thorough health check to make sure the study is a safe and suitable option 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.

Are you a man?
Are you 18 years old or older?
Are you generally healthy with no major ongoing medical conditions?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, Inno8, in different doses. You'll have regular visits to the clinic where the research team will monitor your health very closely. This will involve various assessments, such as blood tests, urine tests, and checking your vital signs like blood pressure and heart rate. These checks help the doctors understand how your body is reacting to the medicine and ensure your safety.

The research team will explain the full schedule, including how many visits are needed and how long each visit might be. They will also let you know the total duration of your involvement in the study, including any follow-up appointments after you've finished taking the medicine.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. A potential benefit of this study is contributing to medical science and helping to develop new treatments that could improve the lives of people with conditions like haemophilia A. While Inno8 is a new medicine, and side effects are possible, the research team will closely monitor you to ensure your safety. They will explain all known or potential risks in detail before you decide to join. 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.

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Unverified
Germany

Common questions

What is haemophilia A?

Haemophilia A is a condition where your blood doesn't clot properly because you're missing a special protein called Factor VIII. This can lead to longer bleeding after injuries.

Will I get haemophilia A from this study?

No, absolutely not. This medicine is for haemophilia, but healthy volunteers will not develop the condition by taking part in this study.

What will I have to do if I join?

You'll take the study medicine, Inno8, and have regular check-ups, blood tests, and other health assessments at a clinic.

Will I get paid to take part?

While the focus is on advancing medical knowledge, sometimes studies offer payment for your time and travel. This would be clearly explained if it applies to this study.

Is this a new medicine?

Yes, Inno8 is a new medicine being tested for the first time in people in this study.