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

Phase 1 first-in-human, single and multiple dosing study of FB301 in healthy female subjects

Scientists are starting a new research study to learn about a medicine called FB301. This medicine is being developed to help women who are experiencing infertility, meaning they are finding it difficult to get pregnant. This study is a very early step, often called 'Phase 1', which means it's the first time FB301 is being given to people. The main goal is to check that the medicine is safe and to understand how the body handles it. They will give different amounts of the medicine to healthy women to see what happens. This research is crucial for understanding if FB301 could potentially be a helpful treatment in the future for women trying to conceive.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Freya Biosciences ApS

Enrolment target

Start

06 Feb 2025

Women infertility

What is this study about?

This research is looking into a new medicine, currently known as FB301, that could potentially help women who are struggling with infertility. Infertility means you're having difficulty getting pregnant. Finding new ways to help with this is really important for many couples and individuals.

This specific study is the very first time FB301 is being tested in people. It’s an early stage of research, sometimes called a 'Phase 1' study. At this stage, the main goals are to make sure the medicine is safe and to understand how it behaves in the human body. Researchers will carefully check for any side effects and see how the medicine is absorbed, used, and cleared from the body.

By carefully studying FB301 in healthy women, scientists can learn important information. This information helps them decide if the medicine is safe enough to be tested in larger groups of people, including women with infertility, in future studies. This is a vital step in developing new treatments for infertility.

Key takeaways

This is an early-stage study (Phase 1) on a new medicine called FB301.
The medicine is being developed to potentially help women with infertility.
The study aims to check the safety of FB301 and how it works in healthy women.
Participants must be healthy women, aged 18 or older.
Taking part means regular clinic visits for medication and health checks.
You won't directly benefit from the medicine but will help future research.

Who may be eligible?

This study is specifically looking for healthy women to take part. To be considered, you must be 18 years old or older – there isn't an upper age limit mentioned, but typically, these early studies might look for a broad adult age range.

Because this is the very first time this new medicine is being given to people, the study needs participants who are generally in good health. This helps the researchers understand the effects of the new medicine without other health conditions getting in the way.

There may be other specific health requirements or conditions that would prevent someone from joining, but these details are not provided here. If you are interested, a healthcare professional would discuss all the detailed criteria with you to see if you are a good fit.

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 a woman?
Are you 18 years old or older?
Are you generally in good health?
Are you able to attend appointments at a study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, FB301. This would involve a series of visits to the study clinic where you would be given the medication, likely both single doses at first and then possibly multiple doses over time. During these visits, the study team would regularly check your health. This might include having blood tests, urine tests, physical examinations, and answering questions about how you are feeling. Throughout the study, you would be closely monitored for any changes or side effects. The total duration of your participation, including follow-up visits after your last dose, would be explained in full by the study team.

Potential risks and benefits

Taking part in any research study carries potential benefits and risks. A potential benefit of this study is contributing to the development of a new medicine that could one day help women with infertility, even though you would not directly benefit from the medicine yourself in this early healthy volunteer study. Potential risks include experiencing side effects from the new medicine, which are not yet fully known, as well as the inconvenience of clinic visits and tests. You would be fully informed of all known risks before joining, and you would 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
Germany

Common questions

What does 'Phase 1' study mean?

Phase 1 means it's the very first time a new medicine is being tested in people. The main goals are to check if it's safe and how the body handles it.

Will I get pregnant if I join this study?

No, this study is not designed to help you get pregnant. It's for healthy women to test the safety of a new medicine for infertility, not as a treatment for infertility itself at this stage.

What is 'FB301'?

FB301 is the coded name for the new medicine being tested. It's a new compound that researchers hope might help with female infertility.

Do I have to be experiencing infertility to join?

No, this particular study is looking for healthy women. It's an early safety test, not a study for treating infertility yet.

Will I be paid to take part?

The information provided doesn't say if participants will be compensated, but this is a common question to ask the research team if you are interested in joining.