RecruitingPHASE1INTERVENTIONAL

A Phase 1 Single Dose and Multiple Ascending Dose Study to Assess the Relative Bioavailability, Food Effect, Safety, Tolerability and Pharmacokinetics of SYT-510 in Healthy Participants

This study is looking for healthy volunteers to test a new medicine called SYT-510. It's a very early-stage study, meaning we're mainly focused on making sure the medicine is safe and understanding how it behaves in the body. We'll be giving different doses to see how well people tolerate it and how their bodies process it. We'll also check if eating food before taking the medicine changes anything. The information gathered from this study, especially how the body handles different doses, will be very important for planning any future research into this new medicine. This kind of early-stage research is crucial for developing new treatments.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Synendos Therapeutics AG

Enrolment target

Start

30 Oct 2024

Estimated completion

31 May 2025

Healthy

What is this study about?

This study is about a new medicine called SYT-510. It's what we call a 'Phase 1' study, which is the very first step in testing a new medicine in people. At this stage, our main goals are to make sure the medicine is safe and to understand how it works in the body. We aren't testing it for a specific illness; instead, we're looking for healthy people to participate.

We'll be giving volunteers different amounts of SYT-510 to see what doses are well-tolerated and how the body handles the medicine over time. We also want to find out if eating food before taking SYT-510 makes a difference to how the body absorbs it. This information is vital because it helps us figure out the best way to give the medicine in future studies. Think of it like a trial run to gather as much basic information as possible.

By taking part, you'd be helping scientists learn crucial details about SYT-510. This early research is a critical step in developing new medicines that could potentially help many people in the future. We want to be thorough and careful at this stage to build a strong foundation for any further development of SYT-510.

Key takeaways

This is a Phase 1 study testing a new medicine called SYT-510 in healthy people.
The main goals are to check the medicine's safety and how the body handles it.
Researchers will look at how different doses work and if food affects the medicine.
Participants will receive either SYT-510 or a placebo.
This early research is crucial for developing potential new treatments in the future.

Who may be eligible?

To join this study, we're looking for healthy men and women who are aged between 18 and 65 years old. Women must not be able to become pregnant during the study. You'll need to have a normal heart tracing (ECG) and your weight should be within a healthy range for your height. Your weight must also be at least 50 kilograms.

There are also some reasons why you might not be able to join. For example, if you have any ongoing health problems that might affect the study results, or if your blood test results are outside the normal range, you wouldn't be able to take part. We also can't include people who have recently used recreational drugs or alcohol, or those who have been part of another drug study in the last three months.

If you've ever had a bad allergic reaction to medicines, food, or other substances, or if you're sensitive to the ingredients in SYT-510, you wouldn't be able to join. Current smokers, or those who have smoked in the past six months, are also not eligible.

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 between 18 and 65 years old?
Are you generally healthy and don't have any major ongoing health problems?
Do you have a healthy weight for your height (BMI between 18 and 30) and weigh at least 50kg?
Have you avoided other drug studies in the last 3 months?
Are you a non-smoker, and haven't smoked in the last 6 months?
Are you a woman who is unable to become pregnant?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the study medicine, SYT-510, or a placebo (a dummy medicine with no active ingredients). This would involve taking a single dose first, and then, if appropriate, taking multiple doses over a period of time. Throughout this time, you would have regular check-ups with the study doctors and nurses. These check-ups would include having blood samples taken to see how your body is handling the medicine, and possibly other tests like heart tracings (ECGs).

There will also be visits to see how food might affect the medicine, which means you might be asked to take the medicine after eating. The study aims to understand how safe the medicine is and how your body processes it. Specific details about the number of visits, how long each visit might be, and the total duration you would be involved will be fully explained to you if you are considered for the study.

Potential risks and benefits

Taking part in any study has potential benefits and risks. While this study is not expected to directly improve your health, you would be contributing valuable information that could help develop new medicines for others in the future. As with any new medicine, there is always a chance of side effects, which could range from mild to more serious. The study team will closely monitor you and explain all known risks. Remember, your participation is completely voluntary, and 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.

Richmond Pharmacology Ltd
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a Phase 1 study?

A Phase 1 study is the very first time a new medicine is tested in people. The main goal is to check how safe it is and how the body handles it, not to treat an illness.

What is SYT-510?

SYT-510 is a new medicine being developed. In this study, we are focusing on understanding its basic properties like safety and how the body processes it.

What does 'relative bioavailability' mean?

It means we're looking at how well the medicine gets into your bloodstream and how much of it gets there, especially comparing different ways of giving it or different conditions, like with or without food.

Will I get the actual medicine or a placebo?

You might get the active medicine (SYT-510) or a placebo (a dummy medicine with no effect). This is common in studies to properly understand the medicine's effects.

Do I need to be ill to join?

No, this study is specifically looking for healthy volunteers. We want to see how the medicine works in people without other health conditions.

How to find out more

Synendos Therapeutics AG

info@synendos.com +41783008789 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.