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

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Zosurabalpin following Intravenous Administration in Healthy Participants

This study is about a new investigational medicine called Zosurabalpin. We are inviting healthy adults, aged 18 and over, to take part. This isn't a study for a specific illness; instead, it's designed to understand how safe the medicine is, if people have any side effects, and how the body processes it. The medicine will be given directly into the bloodstream (intravenously). This is a very early-stage study, meaning it's one of the first times this medicine is being given to people. The information we gather will help us decide if it can be studied further for potential future uses.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

F. Hoffmann-La Roche AG, F. Hoffmann-La Roche AG

Enrolment target

Start

12 Sep 2023

There is no medical condition being investigated. This is a safety and pharmacokinetic study to be performed in healthy participants.

What is this study about?

Imagine a new jigsaw puzzle piece researchers have created for a potential medicine. Before they can even think about what picture the puzzle will make (which would be treating a specific illness), they need to make sure the piece itself is safe and fits well. That's what this study, called 'A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Zosurabalpin', is all about.

Researchers want to learn two main things about a new medicine called Zosurabalpin. Firstly, they want to check if it's safe for people to take, and if there are any side effects (this is called 'safety' and 'tolerability'). Secondly, they want to understand how the body handles the medicine – how it gets into the blood, how it moves around the body, and how the body gets rid of it (this is called 'pharmacokinetics').

This is a very early study, the first time this medicine is being given to humans. It's not looking to treat any health condition, but rather to gather important information in healthy volunteers. The results from this study are crucial because they help scientists decide if this new medicine can be developed further and eventually tested in people who might benefit from it in the future.

Key takeaways

Tests a new medicine, Zosurabalpin.
For healthy adults, not treating an illness.
Aims to understand safety and how the body handles the medicine.
Medicine given through a drip.
Early stage human study (Phase 1).
Participation involves monitoring and follow-up.

Who may be eligible?

This study is open to both men and women who are 18 years old or older. You don't need to have a specific health condition to join, as the study is looking for healthy people.

To be considered for this study, you'll go through a screening process. This will involve health checks and talking to the study team to make sure it's safe for you to take part and that you meet all the specific requirements. They'll also explain what participating involves.

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 18 years old or older?
Are you generally healthy?
Are you able to attend all required appointments?
Are you comfortable with receiving medicine through a drip?
Are you comfortable with blood tests and medical checks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check your health and make sure you're suitable. If you qualify, you'll be given the study medicine, Zosurabalpin, through a drip into your arm (intravenous administration). Over a period of time, the study team will monitor you closely, take blood samples, and perform other assessments to see how your body reacts to the medicine and how it processes it. You'll likely need to stay at a clinic for a certain period, and there will be follow-up visits after you leave. The total duration of your participation, including all visits and follow-ups, will be clearly explained to you before you agree to join.

Potential risks and benefits

Because this is a very early study in healthy people, there isn't a direct health benefit for participants. The main benefit is helping advance medical science. As with any new medicine, there are potential risks, such as side effects from Zosurabalpin or discomfort from procedures like blood tests. All known potential risks will be thoroughly explained to you, and you'll be monitored closely. Remember, 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.

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Unverified
Netherlands

Common questions

What is Zosurabalpin?

Zosurabalpin is a new medicine being investigated. This study is trying to learn more about its safety and how it works in the body.

Will this medicine treat an illness I have?

No, this study is not designed to treat any medical condition. It's for healthy volunteers to understand the medicine better.

How will I take the medicine?

The medicine will be given to you through a drip into your vein (intravenously).

How long will I be in the study?

The exact length of time will be explained to you, but it will include screening, taking the medicine, and follow-up visits.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your future medical care.