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

A Study to Learn How Safe Different Doses of NTS-521 are, What the Amount of NTS-521 in the Body is Over a Period of Time, and What the Effects of NTS-521 on the Body and the Body on NTS-521 are in Adult and Elderly People Receiving Single and Multiple Doses of NTS-521 via an Infusion Directly into a Vein

This is a very early-stage study, the first time a new medicine called NTS-521 will be given to people. The main goals are to find out if different amounts (doses) of NTS-521 are safe and how the body handles the medicine. Researchers will look at how much NTS-521 is in the bloodstream over a period and how the body’s systems respond to it. Theyâ€™ll also see how the body processes and gets rid of the medicine. Participants will receive the medicine through a drip into a vein, either as a single dose or repeated doses. This information is crucial for understanding NTS-521 before it can be studied further for specific health conditions, ensuring it is as safe as possible for future use.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Neurotrauma Sciences LLC

Enrolment target

120

Start

30 Apr 2025

Not applicable

What is this study about?

This is a very early but important study for a new medicine called NTS-521. Think of it like the first time a new car is tested on a track â€“ you want to make sure it's safe to drive and understand how it works before you put it on the public roads. In this case, researchers want to see how safe NTS-521 is when given to people for the very first time.

The main aim of this study is to learn a lot about NTS-521. They want to find out which amounts (doses) are safe for people. They'll also measure how much of the medicine stays in your body over time and how your body reacts to the medicine in terms of how it processes, uses, and gets rid of NTS-521. This helps them understand if the medicine does what they expect and how your body handles it.

Participants will receive NTS-521 directly into a vein through a drip. Some people will get a single dose, and others will get repeated doses. This careful testing is a crucial first step in developing any new medicine. It helps scientists understand its basic properties and safety before it can be tested in people who have specific illnesses. This ensures that any future studies are as safe and well-informed as possible.

Key takeaways

This is the first study of a new medicine, NTS-521, in humans.
The main focus is on safety and how the body processes the medicine.
Participants will receive the medicine through a drip.
The study is for adults aged 18 and over.
It's a foundational step for future potential treatments.

Who may be eligible?

This study is looking for adults aged 18 and over. There is no upper age limit, so both younger and older adults can take part. Participants can be male or female.

Because this is a very early study and not focused on a specific illness, there are no particular health conditions required to join. Generally, people taking part in these kinds of studies are expected to be in overall good health.

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?
Am I generally in good health?
Am I comfortable with receiving medicine through a drip?
Am I available for regular visits to the study clinic?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, NTS-521, through a drip into a vein. Depending on which group you are in, you might get a single dose or repeated doses over a period. You would have regular visits to the study clinic, where doctors and nurses will monitor your health very closely.

During these visits, you'll likely have various assessments. This could include blood tests to check your overall health and measure the levels of NTS-521 in your body, as well as urine tests. They will also check your vital signs like blood pressure, heart rate, and temperature. You will be asked about any side effects you might experience.

The total duration of your participation, including any follow-up appointments after you've received the medicine, will be explained to you in detail by the study team.

Potential risks and benefits

Taking part in a study like this helps researchers understand new medicines and could potentially benefit future patients. However, as NTS-521 is a new medicine, there might be side effects or risks that are not yet known. The study team will explain all known or potential risks to you. 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
Belgium

Common questions

What is NTS-521?

NTS-521 is a new medicine that is being tested in humans for the very first time in this study.

Why is this study being done?

The main goal is to find out if NTS-521 is safe for people, how different doses affect the body, and how the body handles the medicine.

Will this medicine treat my illness?

No, this study is not for treating an illness. It's an early safety study for a new medicine.

How will I receive the medicine?

You will receive NTS-521 through a drip (infusion) directly into a vein.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your medical care.