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

A FIRST-IN-HUMAN PHASE I TRIAL OF OX118 IN HEALTHY VOLUNTEERS

This is a very early study, the first time a new medicine called OX118 is being given to people. It's called a 'Phase I' trial. The main goal is to check if OX118 is safe for humans and to understand how it behaves in the body. Researchers are looking for healthy volunteers to take part, not people with specific conditions. This helps them understand the medicine's basic effects without other illnesses making it complicated. This kind of research is a very important first step in developing new treatments for immune system diseases in the future, by making sure the medicine is safe before testing it on people who are unwell.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Oxion Biologics AB

Enrolment target

Start

19 Mar 2025

Immune system Diseases

What is this study about?

Imagine scientists have created a brand-new key, but they don't yet know if it fits any lock, or even if it's safe to hold. This study, looking at a new medicine called OX118, is a bit like that. It's the very first time this medicine will be given to people. Researchers want to make sure it's safe and understand how it works in the body. They're starting with healthy people, not those with an illness, because it helps them see the medicine's effects clearly without other health problems getting in the way.

The medicine, OX118, is being explored for its potential to help with 'immune system diseases.' Your immune system is your body's defence against illness, but sometimes it can go wrong and attack your own body. This study isn't treating those diseases yet; it's about gathering fundamental information on a new potential tool.

By taking part, healthy volunteers help scientists learn important facts, such as what dose is safe and how the body handles the medicine. This essential first step means that if OX118 proves safe and promising, it can later be tested in people who actually have immune system diseases, hopefully leading to new treatments in the future.

Key takeaways

This is a 'first-in-human' study of a new medicine, OX118.
It aims to check the safety and how the medicine works in healthy people.
It's a Phase I trial, the earliest stage of human testing.
The ultimate goal is to help develop new treatments for immune system diseases.
Taking part means frequent health checks and monitoring by doctors.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. Both men and women can join.

Because this is a study for healthy volunteers, you would need to be generally well and not have any serious ongoing health problems. The healthcare team would check your medical history and do some tests to make sure you are healthy enough to participate.

They will be looking for people who don't currently have any immune system diseases or other conditions that might interfere with how the new medicine works, or put you at extra risk.

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 healthy and don't have any major ongoing medical conditions?
Do you understand this study is for healthy volunteers, not to treat an existing illness?
Are you comfortable with regular hospital/clinic visits for check-ups and receiving medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a full medical check-up to make sure you are suitable. If you are, you would be given the new medicine, OX118, usually for a short period. This might involve several visits to a clinic or hospital for the medicine, blood tests, and other check-ups to see how your body reacts.

During these visits, doctors and nurses would carefully monitor you for any side effects and see how the medicine is processed by your body. You might be asked to keep a diary of how you feel. After you've finished taking the medicine, there would be follow-up appointments to make sure you are still well and to collect any final information. The total length of your involvement would be explained to you before you agree to take part.

Potential risks and benefits

Taking part in any study has potential benefits and potential risks. The main benefit here is contributing to medical science and helping to develop new treatments for immune system diseases in the future. As this is a very early study in healthy people, there isn't a direct health benefit for you. However, you will receive careful medical monitoring. Potential risks include feeling unwell from the new medicine, which could be anything from mild side effects to unexpected serious reactions, as this is the first time it's been given to humans. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Sweden

Common questions

What is a 'first-in-human' study?

It means this is the very first time the medicine, OX118, is being given to people, making it an early step in testing its safety and effects.

Why is this study looking for healthy volunteers?

By testing the medicine in healthy people, researchers can clearly see how it works and what effects it has without other illnesses making it complicated.

What are 'immune system diseases'?

These are conditions where your body's natural defence system mistakenly attacks your own healthy cells, rather than just fighting off infections.

Will I get paid for taking part?

Payment for participation in early-stage trials is common, but you would need to ask the study team directly for details, as it can vary.

How long would I need to be involved?

The exact duration would be explained by the study team, as it can vary. It involves multiple visits for treatment and check-ups, plus follow-up appointments.