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

A study to evaluate the safety, tolerance and changes in blood levels of an anti-toxin drug (FBT-002) in healthy male and female subjects

This study is looking at a new medicine called FBT-002, which might be used as an antidote in the future. It's the first time this medicine will be given to people, so we're starting with healthy volunteers. The main aims are to check if the medicine is safe, to see what dose people can comfortably take, and to understand how it behaves in the body by measuring its levels in the blood. This kind of early study helps us understand if a new medicine has the potential to help patients later on. It’s an essential first step before it can be tested in people who are unwell.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Eurofins Optimed, Fabentech

Enrolment target

Start

20 Dec 2023

Antidote

What is this study about?

This research study is about a new medicine called FBT-002. Think of an antidote as a medicine that can help cancel out the effects of something harmful in the body, like certain poisons or drug overdoses. Before any new medicine can be given to patients who are ill, it first needs to be thoroughly tested.

This particular study is one of the very first steps. We are giving FBT-002 to healthy people, not people who are unwell. This helps us to simply focus on how the medicine affects a normal body. We want to find out if it's safe at different doses and if people can tolerate it well without severe side effects. We also want to understand how the medicine moves into and out of the bloodstream. This information is really important because it helps scientists decide if the medicine is promising enough to continue testing in larger studies, eventually hoping to help people who might need an antidote.

By taking part, healthy volunteers help us gather crucial information. Their participation allows researchers to learn about the medicine's basic properties in humans, which is a vital part of developing new treatments that could potentially save lives or significantly improve health outcomes in the future. Without these first studies in healthy people, it would be impossible to bring new medicines to those who need them.

Key takeaways

This study is testing a new medicine (FBT-002) for the first time in healthy people.
It aims to check the medicine's safety, how much the body can tolerate, and how it moves through the bloodstream.
FBT-002 is being developed as a potential antidote.
Participants must be healthy adults, aged 18 or over, both men and women.
Taking part helps advance medical research, but offers no direct health benefit to you.

Who may be eligible?

This study is looking for healthy adults. To take part, you need to be at least 18 years old. There is no upper age limit, meaning older adults can also participate as long as they meet the other health requirements.

Both men and women are welcome and can take part in this study. The researchers want to get a complete picture of how the medicine affects different people.

Because this is a study for healthy volunteers, you'll need to be in good general health, and the study team will carry out checks to make sure you are suitable.

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 visit the clinic regularly for check-ups and to receive the medicine?
Are you comfortable with having blood tests and other health assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will likely have several visits to the study clinic. These visits might involve various health checks such as blood tests, urine tests, and possibly checks on your heart or other body functions. You will be given the study medicine, FBT-002, by the research team. This will be the first time it's given to people, so you'll be carefully monitored for a period after taking it to ensure your safety and to see how your body reacts.

Researchers will regularly take blood samples to measure how much of the medicine is in your body and how it's being processed. You might also be asked to complete questionnaires about how you are feeling. The exact number of visits, tests, and the total length of your involvement will be explained in detail by the study team, but typically, these early studies might involve a stay at the clinic for a few days, followed by several outpatient visits for follow-up.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The main benefit for you individually is contributing to medical science and helping to develop new treatments that could save lives in the future. As this is a very early study in healthy people, there is no direct health benefit for you from the medicine itself. Potential risks might include side effects from the study medicine, which could be mild (like a headache or feeling tired), or in rare cases, more serious. There might also be discomfort from blood tests or other procedures. 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 usual 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
France

Common questions

What does 'Human Pharmacology (Phase I)' mean?

It means this is one of the very first times the new medicine is being given to people, usually healthy volunteers, to check its safety and how it works in the body.

Why is this study only for healthy people?

By testing on healthy people first, researchers can clearly see how the medicine acts in a normal body without effects from other illnesses, helping them understand its basic safety and dosage.

What is an 'antidote'?

An antidote is a medicine that can help to stop or reverse the harmful effects of certain poisons or excessive amounts of other drugs in the body.

Will I get paid to take part?

Many early-phase studies offer payment for your time and inconvenience. The study team will be able to tell you if this is the case for this particular study.

What if I experience side effects?

The study team will monitor you very closely. Any side effects you report or they observe will be carefully recorded and managed. Your safety is their top priority.