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

A study to learn how different amounts of the study medicine called PF-07941944 are tolerated in the body of healthy adults.

This research study is about a new medicine called PF-07941944. It's a very early-stage study, meaning it's the first time this medicine will be given to people to see how it works in the human body. The main goal is to find out how different amounts of the medicine are handled by the body and whether it's safe. Specifically, researchers are interested in developing treatments for infections like Respiratory Syncytial Virus (RSV), which can cause breathing problems, especially in children and older adults. By studying healthy adults first, scientists can learn important information about the medicine before testing it in people who are unwell. This helps ensure new medicines are as safe as possible.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Pfizer Inc.

Enrolment target

Start

27 Nov 2024

RSV (Respiratory Syncytial Virus)

What is this study about?

This study is looking at a new medicine, or 'study medicine,' called PF-07941944. If you decide to take part, you'd be among the first people to ever receive this medicine. The main aim is to understand how your body reacts to different amounts of this medicine and to check for any side effects. This is a crucial early step in developing any new medication.

The medicine is being developed to potentially help with Respiratory Syncytial Virus (RSV). RSV is a common virus that often causes mild cold-like symptoms, but it can be more serious, especially for young babies and older adults, sometimes leading to infections like bronchitis or pneumonia. Finding new ways to treat or prevent RSV is very important.

Because this is the very first time the medicine is being given to humans, the study starts with healthy volunteers. This allows researchers to carefully observe how the medicine works in a body that isn't already dealing with an illness. The information they gather will help them decide if it's safe and promising enough to continue testing in people who actually have RSV.

Key takeaways

This study is testing a new medicine (PF-07941944) for the first time in healthy people.
The main aim is to check its safety and how the body handles different amounts.
The medicine is being developed for future use against RSV (Respiratory Syncytial Virus).
You must be a healthy adult, aged 18 or over, to be considered.
Participation involves clinic visits and careful monitoring by medical staff.

Who may be eligible?

This study is looking for healthy adult volunteers. If you're 18 years old or older, you might be able to take part. This study is open to both men and women.

Because it's a very early-stage study, participants need to be in good general health. This helps the researchers understand how the medicine works without other health conditions affecting the results.

There might be other specific health checks or conditions that mean you can't join, which the study team will discuss with you. It's important to be honest about your health history so they can make sure the study is safe 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 18 years old or older?
Are you considered generally healthy by a doctor?
Are you comfortable with regular medical check-ups and blood tests?
Are you able to commit to the study schedule and visits?
Are you male or female?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to a clinic. You would receive the study medicine, PF-07941944, and then you would be carefully monitored by doctors and nurses. This monitoring would include regular check-ups, blood tests, and other assessments to see how your body is reacting to the medicine and if there are any side effects. The total length of your participation, including all visits and follow-up checks, would be explained in detail by the study team. You'll be given a clear schedule outlining everything expected of you.

Potential risks and benefits

There isn't a direct personal health benefit for you from taking part in this early-stage study, as it's primarily designed to gather safety information. However, your participation could help scientists learn more about a new medicine that might help others with RSV in the future. As with any new medicine, there are potential risks, including side effects that are currently unknown, or reactions to the medicine. The study team will explain all known and potential risks in detail. 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
Belgium

Common questions

What is RSV?

RSV (Respiratory Syncytial Virus) is a common virus that can cause cold-like symptoms. It can sometimes lead to more serious breathing problems, especially in babies and older adults.

What is the purpose of this study?

The main goal is to see how a new medicine, PF-07941944, is handled by the human body and to check if it's safe, especially when given in different amounts.

Will I get paid for taking part?

Payment for participation to cover time and travel will be discussed by the study team, if applicable.

Is this medicine already approved?

No, this is a very early study for a new medicine. It has not been approved for general use and is only being tested in research.

What does 'first administration to humans' mean?

It means this is the first time this specific medicine is being given to people. Researchers will be very carefully watching how the human body reacts to it.