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

A Study to Learn How Different Amounts of the Study Medicine Called PF-07940369 are Tolerated and Act in the Body in Healthy Adults.

This is a very early stage (Phase I) study of a new medicine, PF-07940369. It's designed for healthy adult volunteers to help doctors understand more about it. The main goals are to see how well different amounts of the medicine are tolerated, meaning if it causes side effects or discomfort, and how the medicine works inside the body. This includes how long it stays in the body and how it's broken down. The information gathered from this study, while done in healthy people, will be crucial for planning future research. Ultimately, this research aims to find better ways to treat a condition called clonal hematopoiesis, which is when some blood cells start to change in an unusual way.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Pfizer Inc.

Enrolment target

Start

05 Aug 2024

clonal hematopoiesis

What is this study about?

This study is about a new medicine called PF-07940369. It's the very first time this medicine is being given to people, specifically healthy adults. Think of it like taking the first cautious steps to understand a new tool. The main goals are quite fundamental: to find out if the medicine is safe at different doses and what it does once it's inside the body – for example, how long it stays there and how it's processed.

The reason we do these early studies in healthy volunteers is to gather important safety information before trying the medicine in people who are unwell. It helps researchers understand how the medicine behaves without the added complexities of an existing illness.

The bigger picture here is a condition called clonal hematopoiesis. This is when certain blood cells start to behave a bit differently, creating a 'clone' of these altered cells. It's a condition doctors are keen to understand better and find ways to manage or treat. While this first study isn't directly treating clonal hematopoiesis, the information learned about PF-07940369 from healthy people is a vital first step towards potentially helping those with the condition in the future.

Key takeaways

New medicine being tested for the first time in humans.
Study involves healthy adult volunteers.
Aims to understand safety and how the medicine acts in the body.
Information will help future research into clonal hematopoiesis.
No direct health benefit expected for participants.

Who may be eligible?

This study is looking for healthy adults. You need to be at least 18 years old – there's no upper age limit, meaning older adults are welcome too. Both men and women can take part in this study.

To be considered healthy, you would generally not have any major ongoing medical conditions that could affect the study results or your safety. The medical team will check this carefully to make sure the study is a good fit 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?
Do you consider yourself a healthy adult?
Are you male or female?
Are you comfortable with regular medical check-ups and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given doses of the study medicine, PF-07940369. The doctors will closely watch how your body reacts and if you have any side effects. You'll have regular visits to the clinic for check-ups, which will likely involve things like blood tests, urine tests, and possibly other simple procedures to see how the medicine is working and how you're feeling.

The study will involve several visits over a period of time, and you might need to stay at the clinic for certain periods, especially after you first take the medicine. This is so the doctors can carefully monitor you. There will also be follow-up appointments after you stop taking the medicine to ensure you are well. The total length of your involvement in the study will be explained in detail before you agree to take part.

Potential risks and benefits

Taking part in a study like this may not offer a direct health benefit to you, as it's designed to gather general information about a new medicine. However, you would be contributing to medical research that could potentially help others in the future who have clonal hematopoiesis. As with any medicine, there are potential risks, such as side effects that are currently unknown because this is a new drug. The study team will explain all known and potential risks to you. Remember, your participation is completely voluntary; you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

—
Unverified
Belgium

Common questions

What is 'clonal hematopoiesis'?

It's a condition where some of your blood cells start to change in an unusual way, forming a group (clone) of these altered cells.

Why is this study only for healthy adults?

This is an early-stage study to understand the new medicine's safety and how it works in the body without the complications of an existing illness.

Will I get better if I join this study?

This study is not designed to treat an illness; its goal is to gather information about a new medicine. There's no direct personal health benefit expected.

What kind of tests will I have?

You can expect regular check-ups, blood tests, and urine tests to monitor your health and how the medicine is affecting your body.

Can I stop participating if I change my mind?

Yes, your involvement is completely voluntary. You can withdraw from the study at any time without giving a reason.