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

A Study to Learn How Different Amounts and Forms of the Study Intervention Called PF-07899895 are Tolerated and Act in the Body of Healthy Adults

This research study is about a new medicine, or 'study intervention,' known as PF-07899895. It's the very first time this medicine is being tested in people. The main goal is to find out how different amounts and ways of giving this medicine are handled by the body of healthy adults. We also want to understand how it acts inside the body. This is a very early stage of testing, often called a 'Phase I' study, which helps us learn about a medicine's safety and basic effects before it's tested in people with specific illnesses like Ulcerative Colitis.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Pfizer Inc.

Enrolment target

Start

31 Oct 2023

Ulcerative Colitis

What is this study about?

This study is all about a new medicine called PF-07899895. Think of it as a very first peek at how this new medicine works. Scientists need to understand how the medicine behaves in the human body, how much is needed, and if it causes any problems, before they can even think about using it to treat illnesses.

Because this is the very first time this medicine is being given to people, it's being tested in healthy adult volunteers. This allows researchers to focus solely on how the medicine acts in a generally healthy body without the complications of a pre-existing illness. They'll be looking at different amounts ('doses') of the medicine and various ways it might be given.

While the medicine is being explored for conditions like Ulcerative Colitis in the future, this current study isn't treating that condition. Instead, it's a vital first step to gather basic safety information and understand how the medicine moves through and is used by the body. This information is crucial for deciding if and how to proceed with further studies in patients.

Key takeaways

This is a very early study looking at a new medicine.
It's the first time this medicine is being tested in people.
The study aims to understand how the medicine behaves in healthy adults.
It's a step towards finding new treatments for conditions like Ulcerative Colitis.
All healthy adults (aged 18 and over) can be considered.

Who may be eligible?

This study is looking for healthy adults to take part. This means people aged 18 years and older are being considered. There's no upper age limit, as long as you're a healthy adult.

Both men and women are welcome to participate in this research. The most important thing is that you are generally healthy, as the study wants to see how the new medicine works in a healthy body.

Specific medical checks will be done by the study team to make sure you are healthy enough to join. They will review your medical history and perform some tests to confirm you meet all the health requirements.

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 able to attend clinic visits regularly?
Are you willing to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be given the study medicine, PF-07899895. This could be in different amounts and forms. You would have several visits to the study clinic, where doctors and nurses would check your health carefully. This might involve blood tests, urine tests, and other health assessments to see how your body is reacting to the medicine.

These visits usually happen quite often at the start, and then become less frequent. The total time you'd be involved in the study would depend on the specific group you're in, but it will be explained in detail before you agree to join. There will also be follow-up calls or visits after your last dose of the medicine to ensure you are well.

Potential risks and benefits

Potential benefits of taking part include helping scientists learn crucial information about a new potential medicine, which could eventually lead to new treatments for illnesses like Ulcerative Colitis. You would also receive close medical attention throughout the study. However, like all medicines, PF-07899895 could have side effects, some of which might be unknown. The study team will explain all known risks to you. You are free 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 Ulcerative Colitis?

Ulcerative Colitis is a long-term condition where the large bowel (colon) and rectum become inflamed, leading to symptoms like tummy pain, diarrhoea, and tiredness.

Why are healthy people being asked to join?

Because this is the first time this medicine is being given to humans, testing it on healthy people helps us learn about its basic safety and how it works in the body without other health problems complicating the results.

Will I be given the real medicine or a dummy pill?

In this early phase, participants will be given different amounts and forms of the active study medicine, PF-07899895. This study aims to gather initial safety and body-response information.

How long will the study last for me?

The exact duration for your participation will depend on which group you are assigned to. This will be fully explained to you by the study staff before you decide to take part.

Will I get paid for taking part?

It is common for early-phase studies like this to provide some payment for your time and inconvenience. This will be discussed with you by the study team if you are interested.