Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to test a single administration of three dose levels of ATX101 in healthy adults.

This study is trying out a new medicine, ATX101, which doctors hope could help people who are very sick with serious infections, known as sepsis or septic shock. Sepsis can make blood vessels leaky, which is very dangerous. This first stage of research, called a Phase I study, will give a single dose of ATX101 to healthy adult volunteers. The main goal is to check how safe different small amounts of the medicine are and what happens to them in the body. By understanding this, scientists can then plan future studies to see if ATX101 can actually treat the leaky blood vessels in people with sepsis.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Aurobac Therapeutics S.A.S.

Enrolment target

Start

07 Jul 2025

Treatment of vascular hyperpermeability in patients with sepsis and septic shock.

What is this study about?

This research study is focused on a new medicine called ATX101. Doctors are interested in this medicine because it might be able to help people who have a very serious condition called sepsis or septic shock. These are severe infections that can lead to life-threatening problems, including something called 'leaky blood vessels' or 'vascular hyperpermeability'. When blood vessels become leaky, it means fluid can escape, which can damage organs and make people even sicker.

This particular study is a 'Phase I' trial. This is one of the very first steps in testing a new medicine in people. It’s not about treating sepsis yet, but about understanding the medicine itself. Researchers will give a single dose of ATX101 to healthy adult volunteers, using three different small amounts. The main things they want to find out are how safe ATX101 is at these low doses and how the body handles it – how it's absorbed, used, and removed. This information is crucial before the medicine can be tested in people who are actually ill with sepsis.

By carefully studying ATX101 in healthy individuals first, scientists can gather important information about its safety and effects. This helps them decide if it's safe enough to move forward with larger studies involving patients who have sepsis. The ultimate goal is to find new and better ways to treat the dangerous complications of sepsis, like leaky blood vessels, and improve the chances of recovery for those who are very unwell.

Key takeaways

This is an early study (Phase I) of a new medicine called ATX101.
It aims to find safe doses and understand how ATX101 works in healthy adults.
The medicine might help people with serious infections like sepsis in the future.
Healthy adults aged 18 and older, both men and women, can potentially join.
Participation involves a single dose and close monitoring for a short period.
There are no direct health benefits for participants, but you contribute to medical research.

Who may be eligible?

This study is looking for healthy adults to take part. This means you should not have any serious health conditions. You need to be at least 18 years old to join this study.

Both men and women are welcome to participate. The study is particularly interested in understanding how the new medicine works in healthy people before it can be considered for those who are ill.

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 18 years old or older?
Are you generally in good health?
Do you not have any serious ongoing medical conditions?
Are you comfortable with receiving an experimental medicine?
Are you able to attend clinic visits for monitoring?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve attending a research clinic for a brief period. You would be given a single, small dose of the study medicine, ATX101. The research team would then monitor your health very closely for a short time to see how your body reacts to the medicine and to make sure it's safe. This would involve a few checks, like blood tests and monitoring your vital signs (such as blood pressure and heart rate). The total duration of your active participation, once you receive the medicine, would likely be for a limited number of hours or days, with follow-up checks as needed. You wouldn't need to take the medicine at home.

Potential risks and benefits

Potential benefits for participants in this 'Phase I' study are generally limited to contributing to medical science and helping understand new medicines. There is no direct medical benefit to participants as they are healthy volunteers. Potential risks include side effects from the study medicine, which will be carefully monitored. Common side effects in early studies are often mild, but serious reactions are possible, though rare. You will be fully informed of all known risks before you decide to take part. Remember, 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
Portugal

Common questions

What is sepsis?

Sepsis is a very serious and life-threatening condition caused by your body's extreme response to an infection. It can lead to organ damage.

Why use healthy people for this study?

In early studies like this (Phase I), new medicines are first tested in healthy volunteers to make sure they are safe and to understand how they work in the body before being given to sick patients.

Will I get paid to join?

The information provided doesn't mention payment. It's common for studies involving healthy volunteers to offer some compensation for time and travel, but you should ask the research team directly.

What is 'vascular hyperpermeability'?

This is a medical term for 'leaky blood vessels'. In severe infections like sepsis, blood vessels can become leaky, which is dangerous for the body's organs.

How long will I be involved in the study?

You'll likely get a single dose and be monitored for a short time, perhaps hours or a few days, depending on how long they need to track the medicine in your body. There might be some follow-up checks.