Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An Accessorised Prefilled Syringe to an Autoinjector Pharmacokinetic Bridging Study of Tozorakimab

This research is looking into a new way to give a medicine called Tozorakimab, which is used to help people with inflammation, especially those with breathing difficulties. Currently, this medicine might be given using an autoinjector. This study aims to check if using a new, pre-filled syringe to give the medicine is just as effective and safe as the existing method. They want to make sure the body handles the medicine in the same way, regardless of the device used. This is important to potentially make it easier and more convenient for patients to take their medication in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

AstraZeneca AB

Enrolment target

100

Start

22 Apr 2025

Inflammation Respiratory

What is this study about?

This study is investigating a medicine called Tozorakimab, which is designed to help with conditions that involve inflammation, particularly those affecting the breathing system. Medicines like this are often given by injection. Currently, it might be given using a device called an 'autoinjector', which is a bit like a pen that helps you inject the medicine easily.

The researchers are looking at a new way to give this medicine: a 'pre-filled syringe'. This is a syringe that already has the correct dose of medicine inside it, ready to use. The main goal of this particular study is to make sure that the body absorbs and uses the medicine from this new pre-filled syringe in exactly the same way it does from the autoinjector. They want to be sure that changing the device doesn't change how effective the medicine is or how the body reacts to it.

This kind of study is called a 'pharmacokinetic bridging study'. This simply means they are bridging the gap between two different ways of delivering the same medicine. If the new pre-filled syringe works just as well, it could potentially offer a simpler and more convenient way for patients to take their medicine in the future. This could lead to more options for people living with inflammatory and respiratory conditions.

Key takeaways

This study is testing a new way to give an inflammatory medicine called Tozorakimab.
It compares a new pre-filled syringe with an existing autoinjector.
The main goal is to ensure the body absorbs the medicine the same way from both devices.
This could potentially lead to easier ways for patients to take their medicine.
It's a Phase I study, meaning it's an early look at how the medicine works in people.
Only adults aged 18 and over can participate.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older, regardless of their gender. Since this is an initial study, it's likely they are looking for generally healthy people to understand how the body handles the medicine.

More detailed health information would be needed to know if you can join. For example, they might check for any specific health conditions you have, other medications you're taking, or if you have any allergies. This is to make sure the study is safe for you and that the results are clear.

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 able to visit a clinic regularly for study check-ups?
Are you prepared to provide blood samples?
Are you generally healthy, or do you have a stable inflammatory/respiratory condition?
Are you willing to follow specific study instructions?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic over a set period. You would receive the Tozorakimab medicine, likely by injection, using either the new pre-filled syringe or the existing autoinjector. Researchers would then take regular blood samples to see how your body handles the medicine over time. You might also have other health checks, such as measuring your vital signs (like blood pressure and heart rate) and answering questions about how you feel. The total duration of your participation, including follow-up, would be fully explained before you agree to join.

Potential risks and benefits

Like any medical study, there can be potential benefits and risks. A potential benefit of taking part is contributing to medical knowledge that could lead to new or improved ways of taking medication for inflammatory conditions. However, there's no guarantee the medicine will directly benefit you. Potential risks could include side effects from the medication, discomfort from injections or blood draws, or allergic reactions. All potential risks would be fully explained before you decide to join. 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
Germany

Common questions

What is Tozorakimab?

Tozorakimab is a medicine being developed to help people with conditions involving inflammation, especially those affecting breathing.

What is a 'pre-filled syringe'?

It's a syringe that comes with the correct dose of medicine already inside, making it easier to use for injections.

Why are they doing this study?

They want to check if giving the medicine with a new pre-filled syringe works just as well as giving it with an autoinjector, to potentially make it more convenient for patients.

Will I get the actual medicine if I join?

Yes, if you join, you would receive the Tozorakimab medicine as part of the study.

Who can join this study?

Adults aged 18 years or older, of any gender, who meet specific health requirements can be considered.