Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Adaptive Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CLE-905-AG, a M1/M4 Muscarinic Agonist when administered alone or in conjunction with a Peripheral Muscarinic antagonist, in Healthy Participants

This early-stage study is looking at a new potential medicine, called CLE-905-AG. It's designed for conditions like schizophrenia. Researchers want to find out if it's safe for people to take, how much of it stays in the body, and how the body handles it. They're also checking how it works when given alone or with another medicine that affects different parts of the body. Healthy volunteers are taking part in this study. This helps scientists understand the medicine better before it's tested in people who have the condition. Your participation helps advance our understanding of new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Clexio Biosciences Ltd.

Enrolment target

110

Start

30 Jul 2025

Schizophrenia

What is this study about?

This study is a very early step in developing a new medicine, called CLE-905-AG. Scientists believe this medicine could potentially help people with conditions like schizophrenia. When new medicines are discovered, they first need to be studied very carefully to make sure they are safe and that we understand how they work in the body.

This particular study is focusing on **safety**, which is the most important thing at this stage. Researchers want to see if the medicine causes any unwanted side effects and how well people tolerate it. They also want to understand **pharmacokinetics**, which is a fancy word for how the body handles the medicine – how it's absorbed, where it goes, how it's changed, and how it leaves the body. This information helps them work out the right dose for future studies.

Because this is such an early stage, healthy volunteers are taking part. This allows researchers to gather initial information about the medicine without the complications of an existing health condition. They're also investigating if combining CLE-905-AG with another medicine that acts on different parts of the body changes how it works. This careful approach helps ensure that any future studies in people with schizophrenia are as safe and effective as possible.

Key takeaways

This is a very early-stage study (Phase 1) for a new medicine called CLE-905-AG.
The main goal is to check the medicine's safety and how the body handles it.
Healthy volunteers are taking part to help gather initial information.
The study is 'double-blind,' meaning no one knows who gets the medicine or placebo.
Your participation helps advance research for conditions like schizophrenia.
You can withdraw from the study at any time.

Who may be eligible?

To take part in this study, you need to be at least 18 years old. Both men and women can join. Because this is an early study, healthy volunteers are typically needed to help us understand the new medicine properly before it's given to people with a health condition.

While the detailed eligibility wasn't provided, normally for studies like this, you would need to be generally in good health. This might mean having no major ongoing health problems, not taking certain medications, and having a normal physical examination and blood tests. Exact criteria will be discussed with you by the study team.

It's important to remember that not everyone who is interested will be able to join. The study team will review your health information carefully to make sure the study is a good fit for you and that taking part would be safe.

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 in good health?
Are you able to attend several clinic visits, possibly including overnight stays?
Are you not currently pregnant or breastfeeding?
Are you willing to avoid certain medications or foods as advised by the study team?
Are you comfortable with blood tests and medical examinations?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a screening visit. This involves a health check, blood tests, and discussions with the study team to see if you are suitable. If you qualify, you would then receive the study medicine, CLE-905-AG, or a placebo (a dummy medicine without active ingredients). This is given as a single dose.

You would have several visits to the clinic, which might involve staying overnight or for several hours, to allow the study team to monitor you closely. They will take blood samples, check your vital signs (like blood pressure and heart rate), and ask about any side effects you might be experiencing. The study will also involve follow-up visits after you've received the medicine to ensure you are well. The total duration of your participation would be explained during your screening visit.

Potential risks and benefits

Taking part in any medical study carries some potential benefits and risks. There's no direct personal health benefit from participating in this early-stage study, as you are a healthy volunteer. However, you will be helping to advance medical science and potentially contribute to the development of new treatments for conditions like schizophrenia. Potential risks include side effects from the study medicine, which could range from mild (like headaches or upset stomach) to more serious ones, though these are carefully monitored. There might also be discomfort from blood tests or other procedures. 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
France

Common questions

What is a 'Phase 1' study?

Phase 1 is the very first stage of human testing for a new medicine. It's mainly to check if it's safe and how the body handles it, usually in healthy volunteers.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It helps researchers understand the true effects of the actual medicine.

Will I know if I'm getting the active medicine or the placebo?

No, this study is 'double-blind,' meaning neither you nor the study team will know if you're receiving the medicine or the placebo. This helps keep the results unbiased.

What does 'pharmacokinetics' mean?

It's about how your body deals with the medicine – how it gets into your system, where it goes, how it's changed, and how it leaves your body.

Why are healthy people needed for a study for schizophrenia?

In early studies like this, healthy volunteers help us understand how the new medicine works and if it's safe without other health conditions making it harder to tell.