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

Safety Assessment of 10-Day Daily Bucco-Oral Administration of Transfer Factor in Healthy Adult Human Subjects

This research is an early study, called a Phase 1 trial, looking at a new medicine called Transfer Factor. The main goal is to find out if it is safe for healthy adults to take. Participants will take the medicine by mouth every day for 10 days. Scientists want to see how the body reacts to this medicine and if there are any side effects. Transfer Factor is being looked at because it might help people with weakened immune systems, for example, those who get recurrent infections. This first study is simply checking for safety in healthy volunteers before it can be explored further for other conditions.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Cepha s.r.o., Aumed a.s.

Enrolment target

Start

15 Oct 2024

healthy subjects It is used in conditions with decreased immunity to enhance it e.g. in case of recurrent and chronic viral infections.

What is this study about?

Imagine your body's immune system as your own personal security guard, protecting you from germs and illnesses. Sometimes, this security guard can be a bit tired or not strong enough, especially if you get sick often. Scientists are looking into something called Transfer Factor, which they hope might help to give the immune system a boost.

This particular study is one of the very first steps in testing Transfer Factor. It's called a 'Phase 1' study, which means it's mainly about safety. In this stage, doctors give the new medicine to a small group of healthy people, not people who are ill. The main aim is to carefully watch for any side effects and to understand how the body handles the medicine. It's really important to find out if a new medicine is safe before it can be tested in people who might benefit from it.

So, this study isn't trying to treat any illness yet. It’s simply checking that healthy people can take Transfer Factor daily for 10 days without experiencing serious problems. The information gathered from this study will help researchers decide if it's safe enough to move on to bigger studies in the future, where they might look at whether it can actually help people with conditions where their immune system needs support, like those who get recurrent viral infections.

Key takeaways

This is a safety study for a new medicine called Transfer Factor.
It's an early-stage trial (Phase 1) involving healthy adults.
Participants will take the medicine daily for 10 days.
The main goal is to check for any side effects.
It aims to see if the medicine is safe for future studies on immune support.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be a healthy adult. This means you generally feel well and don't have any major ongoing health problems or illnesses that would make taking a new medicine risky. The study is open to both men and women.

You must be at least 18 years old to take part. There isn't an upper age limit mentioned, but you'll need to be in good overall health regardless of your age.

The research team will carry out some checks to make sure you're healthy enough for the study. This might include a medical check-up, blood tests, and a look at your medical history to confirm you meet all the 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.

Am I at least 18 years old?
Do I consider myself to be generally healthy?
Do I feel comfortable taking a new medicine for 10 days?
Am I willing to attend appointments for medical checks and tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be taking a medicine called Transfer Factor by mouth every day for 10 days. The study team would give you clear instructions on how and when to take it. Throughout the study, you would likely have some appointments where doctors and nurses would check on your health. This is to make sure you are feeling well and to look for any changes in your body or any side effects from the medicine. They might take blood samples or do other simple tests. There would also be a follow-up period after you finish taking the medicine to ensure everything is still okay. The full duration from your first visit to your last follow-up would be explained to you before you agree to join.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. For this early-stage study, the main benefit isn't a direct improvement to your health, but rather the chance to contribute to medical science and help others in the future by testing the safety of a new medicine. As with any new medicine, there's always a risk of experiencing side effects, which could be mild or, in rare cases, more serious. The study team will monitor you very closely to identify and manage any side effects. Remember, you 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
Czechia

Common questions

What is Transfer Factor?

Transfer Factor is a new medicine being tested to see if it can help improve the immune system, which is your body's defence against illness.

Why is this study only for healthy people?

This is a very early study (Phase 1), designed to first check if the medicine is safe for healthy people before it can be tested in people who might be unwell.

How long will I take the medicine?

You would take the Transfer Factor medicine by mouth every day for 10 days.

Will this medicine treat any illness I have?

No, this study is about checking safety in healthy people, not treating any existing conditions.

What kind of tests will they do?

The study team will likely do medical check-ups and some simple blood tests to monitor your health and look for any side effects.