Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Single Ascending Dose study of ENX-104

Scientists are trying out a new medicine, ENX-104, in people for the very first time. This study is for individuals who have major depressive disorder, which is a type of depression that can be very difficult to live with. The main goal of this early stage, called a Phase 1 study, is to find a safe amount of ENX-104 to give people and understand how their bodies react to it. It also helps to see if there are any side effects. This research won't be looking at whether the medicine cures depression yet, but it’s a crucial first step to learning if ENX-104 could one day become a helpful treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Engrail Therapeutics Inc.

Enrolment target

Start

16 Jul 2024

Major Depressive Disorder

What is this study about?

Imagine your doctor could prescribe a brand new medicine to help with depression. Before that can happen, every new medicine goes through several testing stages to make sure it's safe and works well. This study is one of the very first steps for a new medicine called ENX-104, designed for people who experience major depressive disorder.

In this early stage, which doctors call a Phase 1 study, the main goal isn't to see if the medicine can cure depression right away. Instead, it's about giving small, carefully controlled doses of ENX-104 to a small number of volunteers. The research team will watch closely to see how the body reacts to the medicine, how much of it stays in the body, and what effects it might have. This helps them work out what a safe starting dose might be for future, larger studies.

This type of study is very important because it helps scientists understand the basic properties of a new medicine in humans for the first time. It's a key part of the journey to find new and potentially better ways to help people living with depression. By taking part, volunteers contribute to this vital medical research.

Key takeaways

This is an early study of a new medicine, ENX-104, for depression.
The main goal is to check its safety and how it affects the body.
It's open to adults aged 18 and over, both men and women.
Participation involves regular check-ups and close medical monitoring.
You'll contribute to important research that could help others with depression in the future.

Who may be eligible?

This study is looking for adult volunteers, aged 18 years or older. This means that if you are under 18, you won't be able to take part in this particular research.

Both men and women are welcome to join this study. The researchers want to include a wide range of adults to understand how the new medicine might affect different people.

Of course, there will be other health checks and requirements that you would need to meet to make sure it's safe for you to take part. This will be discussed with you in detail if you are interested.

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.

Am I 18 years old or older?
Do I have a diagnosis of major depressive disorder?
Am I able to attend several appointments for check-ups and tests?
Am I generally in good health, apart from my depression, or are my other conditions stable?
Am I comfortable being one of the first people to try a new medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full health check-up to make sure you are suitable. During the study, you would receive the new medicine, ENX-104, probably as a single dose that may be slightly different from other participants to find the best amount. You would have regular appointments for check-ups, which might include blood tests, talking about how you're feeling, and other assessments. These appointments are designed to monitor your health and how your body reacts to the medicine. The total time you spend involved in the study would depend on the specific visits and follow-up needed, which the study team would explain fully.

Potential risks and benefits

Taking part in any medical study has both potential upsides and downsides. A potential benefit is that you would be contributing to important scientific research that could lead to new treatments for depression in the future. You would also receive close medical attention and monitoring throughout your time in the study. However, because ENX-104 is a new medicine, there might be side effects that are not yet known. The research team will explain all known potential risks to you. Remember, choosing to take part is always your decision, and you have the right to withdraw from the study at any time without giving a reason, and this won't affect any future 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
Netherlands

Common questions

What is 'Major Depressive Disorder'?

It's a serious medical illness that affects how you feel, think, and behave, potentially leading to emotional and physical problems. It's often called clinical depression.

What does 'Human Pharmacology (Phase I)' mean?

It means this is one of the very first times the new medicine is being given to people. The main aim is to check if it's safe and how the body handles it, not yet to cure the illness.

Will I get better if I join this study?

This study is mainly focused on checking the safety and how the body handles the new medicine, not on treating your depression directly. While some people might feel better, there's no guarantee that your symptoms will improve.

What is ENX-104?

ENX-104 is a new medicine being developed specifically for major depressive disorder. It's still in the early stages of testing and not available to the public.

Do I have to pay to join the study?

No, you should not have to pay to participate in the study. In many studies, certain travel costs or other expenses related to your participation might be covered.