AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ST‑905‑AG1 in Healthy Volunteers

This is a very early study, called a Phase 1 trial, looking for healthy people to try a new medicine named ST-905-AG1. Researchers want to understand several important things about this new drug. They will check how safe it is, what side effects it might cause, and how well the body takes it in and uses it. They also want to see what effects it has on the body. This information is really important because it helps scientists learn about the medicine before they can test it on people who actually have conditions like schizophrenia. By studying healthy volunteers first, they can get a good idea of its basic effects and safety.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Syremis Therapeutics Ltd.

Enrolment target

280

Start

08 Jun 2026

Schizophrenia

What is this study about?

This study is a very first step in testing a new medicine called ST-905-AG1. Think of it like a brand new car going through its first safety checks on a test track before being driven on public roads. Doctors want to understand this medicine inside and out before it's ever considered for people with illnesses like schizophrenia.

The main goals are to check how safe the medicine is at different doses. They also want to see how long it stays in the body, how the body breaks it down and gets rid of it, and what kind of effects it has. This is extremely important research because it lays the groundwork for all future studies. If this medicine looks promising and safe in healthy volunteers, it could eventually be developed further to help people living with schizophrenia.

While the medicine might eventually be used for schizophrenia, this particular study is *not* looking for people with schizophrenia. Instead, it's focusing on healthy individuals to get a clear picture of how the medicine works in a body that isn't already dealing with health conditions. This helps researchers understand the basic effects of the medicine itself.

Key takeaways

This is an early-stage study testing a new medicine (ST-905-AG1) for the first time in people.
It aims to find out how safe the medicine is and how the body handles it.
The study is looking for healthy volunteers, not people with schizophrenia.
You must be 18 years or older, and both men and women can participate.
Participation involves clinical visits, taking the new medicine, and close medical monitoring.

Who may be eligible?

To join this study, you need to be a healthy person, which means you generally don't have any major ongoing health problems.

You must be at least 18 years old. There's no upper age limit mentioned, so older adults could also be considered.

Both men and women are welcome to take part in this study, provided they meet all the other 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 generally healthy with no major ongoing medical conditions?
Are you 18 years old or older?
Are you able to commit to the study visits and requirements?
Are you comfortable potentially taking a new, untested medicine?
Are you able to understand and follow study instructions?

Answer every question to see your result.

What does participation involve?

This study involves taking a new medicine, ST-905-AG1, for the first time in humans. You would likely visit the study clinic multiple times for medical checks, blood tests, and to receive the medication. You might stay overnight at the clinic for some periods so doctors can monitor you closely, especially after you first take the medicine. They will check your vital signs (like heart rate and blood pressure) and ask about any side effects. The total duration of your participation could be a few weeks or more, depending on the specific schedule, with some follow-up calls or visits after your last dose. All procedures will be carefully explained to you beforehand.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, but your contribution could help advance medical knowledge and potentially lead to new treatments for others in the future. As with any new medicine, there's a risk of unknown side effects, which could range from mild to more serious. You will be closely monitored by medical staff for any reactions. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
France

Common questions

What is schizophrenia?

Schizophrenia is a long-term mental health condition that can cause a range of different psychological symptoms, making it hard to tell the difference between what's real and what isn't.

Why are you testing this medicine on healthy people?

We test new medicines on healthy people first to understand how safe they are and how the body handles them, without having other health issues complicate the results. This is a standard first step.

Will I get the medicine or a dummy pill (placebo)?

The information provided doesn't specify, but in early-stage trials, participants usually receive the active medicine, sometimes at different doses. You'll be told exactly what to expect if you join.

Will I be paid for taking part?

Many clinical trials offer compensation for your time and travel. If you are interested, you should ask the study team about payment or reimbursement.

What if I feel unwell during the study?

You will be closely monitored, and medical staff will be available to help you immediately. You can also withdraw from the study at any point if you feel unwell or for any other reason.