Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Safety and tolerability of single and multiple ascending doses of lunsekimig (SAR443765) in healthy participants

This early-stage study is looking into a new medicine called lunsekimig, which could one day be used to treat asthma. The main goal is to check if the medicine is safe when given in different amounts, and how well healthy people can cope with it. This is typically the first time a new medicine is given to people. Researchers will give volunteers single doses and then increasing doses to see how their bodies react. This information is very important for planning future studies that will hopefully involve people who actually have asthma. It's a crucial step in developing new treatments, helping to understand potential side effects and the right amount to give.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sanofi-Aventis Recherche & Developpement

Enrolment target

128

Start

18 Apr 2024

Asthma

What is this study about?

This study is about a new medicine called lunsekimig. While it might sound a bit complex, the main idea is quite simple: researchers want to find out if this new medicine is safe for people and what the best amount (dose) to give is. This type of study is called a 'Phase I' trial. It's usually the very first time a new medicine is tried in people, and it often starts with healthy volunteers before moving on to people who have the actual illness.

The reason they start with healthy people is to carefully check for any side effects and how the body handles the medicine without the added complications of an illness. Think of it like testing a recipe for the first time – you want to make sure the ingredients are safe before serving it to someone who needs the nutrients.

Even though this study is focused on healthy people, the information gathered is very important for future steps. It helps scientists understand if lunsekimig has the potential to become a treatment for asthma. If it's found to be safe and well-tolerated in this study, it can then move on to bigger trials involving people who live with asthma, to see if it actually works to improve their breathing.

Key takeaways

This is an early study of a new asthma medicine called lunsekimig.
It aims to check the medicine’s safety and how well people can tolerate different doses.
The study involves healthy adult volunteers, both men and women.
Participation includes regular health checks and receiving the study medicine.
It's a crucial step in developing new treatments for asthma.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

Because this is a study for healthy volunteers, you would generally need to be in good overall health and not have any serious medical conditions. The doctors and nurses running the study will check your health very carefully to make sure it's safe for you to participate.

They will explain everything and ask you questions about your medical history and any medicines you are currently taking. This helps them ensure that the study is right for you and that your safety is their top priority.

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 in good health?
Are you willing to attend regular appointments?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new medicine, lunsekimig. This would be given at different times, starting with a single dose, and then later, possibly multiple doses over a period. You would have regular check-ups with the study doctors and nurses, which might include blood tests, urine tests, heart checks (like an ECG), and keeping track of any feelings or symptoms you experience. The exact number of visits and the full duration of your involvement, including follow-up, would be fully explained before you agree to join.

Potential risks and benefits

The main benefit of taking part in such an early study is helping advance medical science and potentially developing new medicines for conditions like asthma. You would also receive careful medical monitoring. However, there's always a chance of unknown side effects, as this is a new medicine. Any potential risks will be fully explained before you join, and you have the right to withdraw from the study at any time without giving a reason.

Locations (1)

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

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Unverified
Belgium

Common questions

What is lunsekimig?

It's a new medicine that is being tested to see if it's safe for people. It might eventually be used for asthma.

Why are healthy people needed for this study?

Because it's the very first time this new medicine is given to people, researchers need to check its safety and how the body handles it in people who are generally well.

Will this medicine cure my asthma?

This study is not testing if the medicine works for asthma. It's only looking at its safety and how well people tolerate it at this early stage.

What happens if I feel unwell during the study?

The study team will monitor you very closely. You should tell them immediately if you feel unwell, and they will provide care and guidance.

Do I get paid to take part?

Sometimes studies offer payment for your time and travel, but this would be something to ask the research team directly.