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

A Randomised, Placebo-Controlled, Double-blind, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Intravenous Administration of IRX-010 in Healthy Participants

This early-stage study, called a Phase 1 trial, is investigating a new medication known as IRX-010. The main goal is to find out if IRX-010 is safe for people and how their bodies process it after it’s given through a drip (intravenous). This is the very first time this medicine is being given to humans. Researchers are particularly interested in its potential for treating inflammatory conditions. Healthy adult volunteers are needed to take part. The study is designed so that neither the participant nor the study team knows whether the participant is receiving the new medicine or a dummy treatment (placebo), which helps ensure the results are fair and unbiased. Your safety and well-being will be a top priority throughout the study.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Immunorx Pharma Inc.

Enrolment target

Start

10 May 2023

Inflammatory disease

What is this study about?

This study is an early step in testing a new medicine called IRX-010. It's designed for people who have inflammatory diseases, which are conditions where your body's immune system mistakenly attacks healthy tissues, causing pain, swelling, and other problems. Because this medicine is new, the first thing researchers need to understand is whether it's safe for people to take and to learn how the body deals with it.

This type of study is called a Phase 1 trial. It's like a first test drive for a new car – the main focus isn't on how well it works yet, but on making sure it's safe to operate. Healthy adult volunteers are invited to take part because their bodies are generally predictable, making it easier to spot any effects of the new medicine. The information gathered from this study will help decide if IRX-010 can continue to be tested in larger studies with people who actually have inflammatory diseases.

The study also uses a 'double-blind, placebo-controlled' design. This means that neither you nor the study team will know if you are being given the new medicine (IRX-010) or a 'dummy' treatment (a placebo) that looks the same but contains no active medicine. This is a common and important way to make sure the study results are fair and unbiased. You might receive a single dose or several doses, and the researchers will carefully watch how your body reacts.

Key takeaways

This is an early study of a new medicine (IRX-010) for inflammatory diseases.
It's the first time this medicine is being given to people.
The main goals are to check its safety and how the body handles it.
Healthy adults aged 18 and over are needed.
You might receive the new medicine or a dummy treatment.
Your health will be carefully monitored throughout the study.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 or older. The study is open to both men and women.

Being 'healthy' generally means you don't have any significant ongoing medical conditions that could interfere with the study medicine or your safety while participating. The study team will conduct thorough checks to make sure you fit these criteria and that it's safe for you to take part.

They will ask questions about your health history and do some medical tests to confirm you are suitable. This helps to protect your safety and ensure the results of the study are clear.

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 considered generally healthy?
Are you able to attend several clinic visits?
Are you comfortable with having blood taken and receiving medication through a drip?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, it would involve a number of visits to a clinic. You would receive the study medicine, or a placebo, through a drip (into your vein). This might happen once, or you might receive it multiple times over a period. During your visits, the study team would carefully monitor your health and take regular blood and urine samples to see how your body reacts to the medication and how it processes it. They would also perform routine checks like measuring your blood pressure, temperature, and heartbeat.

You would need to attend follow-up appointments to make sure you are doing well even after you've received the medicine. The total duration of your involvement, including all visits and follow-ups, would be explained to you in detail by the study team. They will make sure you understand the time commitment involved before you make a decision.

Potential risks and benefits

While we hope that IRX-010 could potentially help people with inflammatory diseases in the future, it's important to remember that as a healthy volunteer in this early study, there will be no direct medical benefit to you. The potential benefit lies in contributing to medical knowledge and helping develop new treatments for others. Like all medications, IRX-010 may have side effects, which could be mild, moderate, or, in rare cases, serious. The medical team will carefully monitor you for any reactions. You will be fully informed of all known or potential risks before you decide to participate, and importantly, you are free to withdraw from the study at any time, for any reason, without it affecting your 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 an 'inflammatory disease'?

Inflammatory diseases are conditions where your body's immune system mistakenly attacks its own healthy tissues. This can cause pain, swelling, and other problems in different parts of the body.

What does 'Phase 1 study' mean?

A Phase 1 study is the first time a new medicine is given to humans. Its main purpose is to check for safety and understand how the body handles the medicine, not yet to see if it treats a disease.

Will I get the actual medicine or a dummy treatment?

This study is 'double-blind,' meaning neither you nor the study team will know if you're getting the new medicine (IRX-010) or a dummy treatment (placebo). This helps make the study results fair.

What does 'intravenous administration' mean?

It means the medicine will be given directly into your vein, usually through a drip in your arm.

Will I be paid to take part?

The study team will be able to tell you if there is any compensation for your time and travel expenses. This will be openly discussed with you before you agree to participate.