Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Study to Learn How Different Amounts of the Study Medicine Called PF-07328948 are Tolerated and Act in the Body in Healthy Adults

This clinical trial is designed for healthy adults to explore a new potential medicine named PF-07328948. The main goals are to understand how well different amounts, or 'doses', of this medicine are tolerated by the body and how it acts once it's taken. This is a very early stage of research, often called a Phase 1 study, which means it helps scientists learn fundamental information about a new drug's safety and how it behaves in humans for the first time. Please note, while the medicine might eventually be researched for conditions like heart failure, this specific study is for healthy volunteers only and does not involve treating any existing health problems. Your participation could help advance medical understanding.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

15 Mar 2024

Heart failure

What is this study about?

This study is an early step in developing a new medicine, which for now is called PF-07328948. Think of it like a very first test drive. We're inviting healthy adults – that's people who don't have any major medical conditions – to help us understand this new drug better. The main things we want to find out are what different amounts of the medicine are safe to give, and how the medicine behaves in the body after someone takes it. This involves seeing how it's absorbed, how it's broken down, and how quickly it leaves the body.

This kind of study is called a 'Phase 1' study, and it's a really important stage in medical research. Doctors and scientists need this basic information before they can continue testing the medicine in people who are unwell. For example, if a medicine is eventually going to help people with heart failure, we first need to make sure it's safe for humans and understand its basic effects.

It's important to know that this study is not designed to treat any medical condition, including heart failure. Instead, it's about gathering essential information on a new drug. Your participation as a healthy volunteer would be invaluable in helping medical science move forward and potentially lead to new treatments in the future.

Key takeaways

New medicine PF-07328948 is being tested for the first time in healthy adults.
The main aims are to check safety and how the medicine works in the body.
This is an early-stage study, not a treatment for heart failure.
You must be 18 or older and generally healthy to be considered.
Participation involves clinic visits, taking the medicine, and various health checks.
You can stop participating at any time.

Who may be eligible?

This study is looking for healthy adults. You might be able to take part if you are 18 years old or older, and there's no upper age limit, meaning older adults can also participate.

Both men and women are welcome to join this study. The most important thing is that you are generally healthy and don't have any major ongoing medical conditions that could make taking the study medicine unsafe or affect the results.

Detailed health checks will be done by the study team to make sure it's safe for you to participate and that you meet all the specific health requirements for this particular medicine. They will discuss your full medical history with 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 generally healthy with no major long-term health problems?
Are you comfortable visiting a clinic for multiple appointments and potentially overnight stays?
Are you willing to have regular blood tests and other health checks?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the study clinic, which might include overnight stays. During these visits, you'll be given doses of the study medicine, PF-07328948. The researchers will observe you closely to see how you respond. You'll likely have various assessments, such as blood tests, urine tests, heart checks (like an ECG), and measurements of your vital signs (blood pressure, temperature, etc.). These tests help the researchers understand how the medicine is working and if it's causing any effects in your body. There might be a follow-up period after your last dose, where you return to the clinic for a final check-up. The total time you'd spend involved with the study, including all visits and follow-ups, would be explained to you fully before you decide to join.

Potential risks and benefits

Potential benefits of taking part include contributing to medical science and helping to develop future treatments, though there's no direct personal health benefit expected as this is a first-in-human study in healthy people. You may also receive compensation for your time and travel. Potential risks, like with any new medicine, could include side effects that are currently unknown, or reactions to the study drug. These could range from mild discomfort to more serious, although unexpected, issues. The study team will closely monitor you for any problems. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care, if you decide it's not for you.

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 PF-07328948?

It's the name of a new medicine being tested. It doesn't have a common name yet, as it's still in early research stages.

Why is this study for healthy adults, not people with heart failure?

This is a very early study (Phase 1) to check basic safety and how the medicine acts in the body. This crucial step is done in healthy volunteers first, before testing in people with specific conditions like heart failure.

Will I get paid to take part?

Many early-stage trials offer some payment for your time, travel, and inconvenience. This would be explained to you by the study team before you agree to join.

What kind of tests will I have?

You'll likely have blood and urine tests, heart checks (ECGs), and checks of your blood pressure and temperature. These help researchers understand how the medicine is affecting your body.

Can I leave the study at any time?

Yes, absolutely. You have the right to withdraw from the study at any point, for any reason, and it won't affect your regular medical care.