RecruitingPHASE2INTERVENTIONAL

A Phase 2a Efficacy, Safety, Tolerability, and PK Study of SYT-510 in Participants With Generalized Anxiety Disorder

This research is looking into a new medicine, SYT-510, for people who experience Generalised Anxiety Disorder (GAD). The study is in an early stage (Phase 2) and aims to see how well a single dose of SYT-510 works, how safe it is, and how the body handles it. Participants will receive either SYT-510 or a 'dummy' pill (placebo) on separate occasions, with a break in between. This helps researchers compare the effects of the new medicine fairly. The findings will help inform bigger studies in the future, guiding whether SYT-510 could be a helpful treatment option for anxiety.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Synendos Therapeutics AG

Enrolment target

Start

22 Apr 2026

Estimated completion

01 Jan 2027

Generalized Anxiety Disorder

What is this study about?

This study is designed to explore a new potential medication called SYT-510 for a condition known as Generalised Anxiety Disorder, or GAD. GAD is a common anxiety disorder where someone experiences ongoing and excessive worry about many different things, making it hard to control and often affecting daily life.

The main goal of this particular study is to understand several important things about SYT-510. Researchers want to see if a single dose of the medicine can help reduce anxiety symptoms. They also want to check how safe it is and if people can tolerate it well (meaning they don't have too many uncomfortable side effects). On top of that, they'll be looking at how the body processes the medicine – how it's absorbed, used, and cleared out. This information is really important because it helps scientists decide if SYT-510 is worth studying further in larger groups of people and developing into a potential new treatment.

This study uses a clever design where each participant will receive both SYT-510 and a 'dummy' pill (called a placebo) at different times, with a break in between. This allows researchers to directly compare how people feel and respond to the actual medicine versus no active medicine, which gives them very clear results. The insights gained from this study are crucial for planning future, bigger studies that could eventually lead to new ways to support people with anxiety.

Key takeaways

The study is testing a new medicine (SYT-510) for Generalised Anxiety Disorder (GAD).
It's an early-stage study looking at safety and how well a single dose works.
Participants will receive the new medicine and a 'dummy' pill on separate visits.
The study aims to understand how the medicine affects anxiety and how the body handles it.
Findings will help decide if bigger studies of SYT-510 are needed in the future.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be a man or woman between 18 and 55 years old. You must be right-handed and have been diagnosed with Generalised Anxiety Disorder (GAD) but not currently taking any medication for it. Your body mass index (BMI) should be between 18 and 30, and you need to weigh at least 50 kg.

There are also some important rules about birth control during the study, as well as an agreement not to donate sperm or eggs for three months after your last study visit. You must be able to understand the study information, give your written consent to take part, and be willing to follow all the study instructions carefully.

Some reasons you might not be able to join include having certain long-term health problems (like heart, kidney, or liver issues) that could interfere with the study. You also can't take part if you have major depression, severe depression symptoms, learning difficulties, or a history of drug or alcohol misuse in the last six months. The study is specifically for GAD, so if you have another main mental health diagnosis, you might not be 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 55 years old?
Do you have a diagnosis of Generalised Anxiety Disorder (GAD) but aren't currently taking medication for it?
Are you generally healthy and right-handed?
Is your weight suitable for the study (BMI between 18 and 30, at least 50 kg)?
Are you able to agree to the study's contraception rules?
Are you able to understand the study and follow its instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable for the study. If you qualify, you'll enter the main study. This study involves two visits to the clinic where you'll receive either the study medicine, SYT-510, or a 'dummy' pill (placebo). These two visits will be separated by a 'washout' period of 7 to 14 days, which is a break to ensure the effects of the first dose have left your system before you receive the second. During these visits, researchers will monitor your health, take blood samples to see how the medicine is processed by your body, and ask you to complete questionnaires or tasks to assess your anxiety levels and how you're feeling. The total duration of your involvement in the study, from your first dose to your last follow-up, will be relatively short, likely a few weeks, given it's a single-dose study.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing an investigational medicine that might help your condition, as well as contributing to medical knowledge that could help others in the future. However, there are potential risks, including side effects from the study medicine which may not yet be fully known, or discomfort from study procedures like blood tests. You might also find that the medicine doesn't help your anxiety. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

SLaM
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Generalised Anxiety Disorder (GAD)?

GAD is when someone worries excessively about many different things, often daily, making it hard to control the worry and affecting their life.

What is a 'dummy' pill or placebo?

A placebo is a pill that looks like the study medicine but contains no active ingredients. It's used to compare the effects of the actual medicine fairly.

What does 'single dose study' mean?

It means you'll receive a dose of the study medicine (or placebo) on two separate occasions, but not continuously over time, allowing researchers to see its immediate effects.

Will I know if I'm getting SYT-510 or the placebo?

No, this type of study is usually 'blinded', meaning neither you nor the study team will know which treatment you're receiving at each visit until after the study ends.

What is a 'washout period'?

It's a break between receiving the two different treatments (SYT-510 and placebo) to ensure the effects of the first dose have gone before you take the second.

How to find out more

Andrea Chicca

andrea.chicca@synendos.com +41783008789 Official trial record

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