Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to examine the effects of oral NTX-1955 on the brain in healthy adults.

Researchers are conducting a study to understand how a new medication called NTX-1955 affects the brain. This is an early stage, or 'Phase I', study, meaning they are primarily checking its safety and how it works in healthy adult volunteers, rather than treating an illness directly. The main goal is to see if NTX-1955 could potentially be helpful for people who experience generalised anxiety disorder (GAD) in the future. GAD is a condition where people feel worried or anxious most of the time about everyday things. By studying healthy adults first, scientists can learn important information about the medicine before considering it for patients with anxiety.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Newleos Therapeutics Inc.

Enrolment target

Start

24 Jun 2025

Generalized Anxiety Disorder (GAD)

What is this study about?

This research study is an early step in developing a new medicine, NTX-1955. Think of it like testing a new car on a track before letting it on the main roads. Scientists want to understand how this medicine works inside the human body, specifically how it affects the brain. They are giving NTX-1955 by mouth to healthy adult volunteers to see what happens.

The main reason for this study is to explore if NTX-1955 could eventually help people who have a condition called generalised anxiety disorder, often shortened to GAD. GAD is when someone feels worried or anxious about many different things, most days of the week, often for a long time. These worries can be hard to control and can affect daily life.

By carefully studying how NTX-1955 interacts with the brain in healthy people, researchers hope to gather important information. This information will help them decide if it's safe and promising enough to move on to further studies where it might be tested in people who actually have generalised anxiety disorder. This step-by-step approach is how new medicines are developed to ensure they are as safe and effective as possible.

Key takeaways

This is an early-stage study of a new medicine called NTX-1955.
The study aims to understand how NTX-1955 affects the brain in healthy adults.
It's being explored as a potential future treatment for generalised anxiety disorder.
Participants must be healthy adults, aged 18 or older.
Both men and women can take part in the research.

Who may be eligible?

This study is looking for healthy adult volunteers. To take part, you must be 18 years old or older – there is no upper age limit, meaning people of any adult age can apply.

Both men and women are welcome to participate in this research. The researchers specifically need healthy individuals because they want to understand how the medicine works without other health conditions affecting the results.

While the study description doesn't list many specific exclusions, typically, you would need to be in good general health, not be taking certain medications, and not have any serious ongoing medical conditions. If you're interested, the study team would ask you some questions to make sure you're a good fit.

Quick self-check

Are you 18 years old or older?
Are you a healthy adult, generally free from major illnesses?
Are you able to take medication by mouth?
Are you comfortable attending multiple appointments at a clinic?
Are you prepared to follow study instructions carefully?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would likely need to visit the study clinic several times. During these visits, the research team would give you the study medication, NTX-1955, to take by mouth. They would then carry out various assessments. These might include blood tests, checking your vital signs like blood pressure and heart rate, and possibly brain scans or other tests to see how the medicine is affecting your brain function.

You would be carefully monitored throughout the study to ensure your safety and to collect all the necessary information. The total duration of your participation, including any follow-up appointments after you've finished taking the medication, would be explained to you in detail by the study team. You'll be given a clear schedule of when you need to attend and what to expect at each appointment.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as contributing to scientific knowledge that could help future patients with anxiety. You would also receive close medical attention during the study. However, there are also potential risks, which will be fully explained to you. These could include side effects from the study medication, and the possibility that the medicine might not work as expected. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What is 'Phase I' of a study?

Phase I is the very first stage where a new medicine is tested in people. It mainly checks if the medicine is safe and how it works in the body, usually in healthy volunteers.

What is NTX-1955?

NTX-1955 is the name of the new experimental medicine being tested in this study. It's being investigated for its potential effects on the brain.

What is Generalised Anxiety Disorder (GAD)?

GAD is a common condition where someone experiences excessive worry and anxiety about everyday life events for most days, often for six months or more.

Do I have to have anxiety to join this study?

No, this specific study is looking for healthy adults. It's an early step to understand the medicine before it's tested in people with anxiety.

Will I be paid to take part?

The study information doesn't say, but many studies offer payment or cover expenses for your time and travel. You should ask the study team about this.