Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Study with healthy volunteers to investigate the safety, tolerability, blood concentration and some effects of various amounts of the pharmaceutical substance SR-878

This research study is for healthy volunteers and is designed to test a new medicine called SR-878. The main goals are to make sure the medicine is safe and that people can take it without too many problems (tolerability). They'll give different amounts of the medicine to see how it affects the body and how much of it gets into the bloodstream. This type of study, called a Phase I study, is always the first step for a new medicine in people. It helps scientists understand how the medicine works at a very basic level before it's given to people who are unwell. If you're 18 or over and generally healthy, you might be able to take part.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

SciRhom GmbH

Enrolment target

Start

11 Mar 2024

Healthy Volunteers

What is this study about?

Imagine scientists have developed a new medicine and now they need to see how it works in people for the very first time. That's what this study is all about. It's for healthy volunteers, meaning people who don't have any major health problems. The medicine they're testing is called SR-878.

The main aim of this study is to check if SR-878 is safe for people to take and to see if there are any side effects. They'll also be looking at how much of the medicine gets into your blood and how long it stays there. This helps them work out the right dose for future studies. They'll also be checking for any early signs of what the medicine does to the body.

This is a very early stage of testing for a new medicine. It's called a 'Phase I' study. These studies are crucial because they provide important information that helps doctors and scientists decide if the medicine can go on to be tested in people who actually have the condition it's designed to treat. It's an important step in bringing new treatments to patients.

Key takeaways

This study is testing a new medicine called SR-878 for the first time in people.
It's open to healthy volunteers aged 18 and over.
The main goals are to check the medicine's safety, how it's tolerated, and how it behaves in the body.
This is an early-stage study, crucial for gathering basic information.
Your participation could help advance medical science for future treatments.

Who may be eligible?

This study is looking for people who are generally healthy. You need to be at least 18 years old to take part, and there's no upper age limit. Both men and women can join.

Because this is a study for healthy volunteers, the researchers will need to make sure you don't have any serious ongoing health conditions that could affect how the medicine works or put your health at risk. They will do some checks, like blood tests, to confirm you meet 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 at least 18 years old?
Are you generally healthy with no major ongoing medical conditions?
Are you able to attend clinic visits as required?
Are you comfortable with having blood tests and other routine checks?
Are you willing to follow specific study instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medicine, SR-878, usually in a research clinic. You'll have regular check-ups, which will likely involve having your blood taken and possibly some other simple tests to see how the medicine is affecting you. The study will look at different amounts of the medicine, so you might receive a specific dose. The researchers will explain exactly how often you'll need to visit and for how long. There will also be follow-up appointments after you've finished taking the medicine to make sure you're still doing well.

Potential risks and benefits

Participating in research always carries some risk, as with any medicine, you might experience side effects. The study team will explain all known potential risks before you decide to join. For healthy volunteers, a direct medical benefit isn't expected, but you'll be contributing valuable information that could help others in the future. 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
Austria

Common questions

What does 'healthy volunteer' mean?

It means you generally don't have any major medical conditions, and you're not taking medications that might interfere with the study medicine.

Will I get paid for taking part?

Many clinical trials offer some payment for your time and expenses. The study team will tell you if this is the case for this study.

What is SR-878?

SR-878 is a new pharmaceutical substance being tested. Its exact purpose isn't specified in this early-stage study, as the focus is on its basic safety and how it works in the body.

How long will the study take for me?

The study team will give you a clear idea of the total time commitment, including how many visits and how long each visit might be.

Will I know if I received the actual medicine?

In some 'blinded' studies, you might not know if you received the active medicine or a placebo (dummy medicine). The researchers will explain this aspect to you.