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

A clinical study investigating OM-85-IN safety and tolerability in healthy volunteers and mild allergic asthma patients

This research study is investigating a new treatment called OM-85-IN. It's specifically for people who have mild allergic asthma. The study also includes healthy volunteers, who don't have asthma. The main purpose of this early-stage study is to carefully check if the treatment is safe for people to take and to see how their bodies react to it. This means researchers will be looking for any side effects and how well people cope with the new medication. This kind of study is a crucial first step when developing new medicines, ensuring they are safe before they can be tested on more people.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

OM Pharma S.A.

Enrolment target

Start

17 Oct 2023

Mild allergic asthma

What is this study about?

You've landed on information about a research study looking into a new potential treatment called OM-85-IN. Think of it like a brand new recipe that hasn't been tried out much yet. Scientists have developed this new treatment and believe it might help conditions like mild allergic asthma.

The main aim of this particular study is very straightforward: to see if this new treatment is safe for people to take and to understand how their bodies react to it. This is called 'safety and tolerability'. It's the very first time this treatment is being given to humans, which is a big and important step in developing new medicines. They want to make sure it doesn't cause any serious problems and that people can take it without too many uncomfortable side effects.

By carefully studying how healthy volunteers and people with mild allergic asthma react to OM-85-IN, researchers can gather vital information. This helps them decide if the treatment is promising enough to continue with further, larger studies in the future, which would then look into whether it actually works to improve asthma symptoms.

Key takeaways

This study is testing a new treatment called OM-85-IN for safety.
It's open to healthy adults and those with mild allergic asthma.
This is an early-stage study, the first time it will be given to people.
Participation involves clinic visits and careful health monitoring.
You have the right to leave the study at any time.
The main aim is to understand side effects, not to cure asthma.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 years or older. There is no upper age limit for taking part.

The study is looking for two main groups of people: healthy volunteers who don't have any significant health problems, and people who have been diagnosed with mild allergic asthma. This means your asthma symptoms are generally mild and often triggered by things like pollen, dust mites, or pet dander.

Both men and women are welcome to participate in this study. The research team will have a more detailed list of things that might make someone suitable or unsuitable, so if you're interested, it's best to speak with them directly or with your GP.

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?
Do you have mild allergic asthma, or are you generally healthy?
Are you able to attend appointments at a study clinic?
Are you comfortable with taking a new, experimental medication?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a series of visits to a clinic or research centre. During these visits, the research team would carry out different assessments, which might include health check-ups, blood tests, and possibly breathing tests if you have asthma. You would receive the study medication (OM-85-IN) during these visits, and the team would closely monitor how you are feeling and reacting to it. You would also have follow-up appointments to ensure everything is well after you've taken the medication. The total duration of your participation, including all visits and follow-ups, would be explained in full by the research team.

Potential risks and benefits

Potential benefits of taking part could include contributing to medical science and helping to develop new treatments for asthma, which might help others in the future. You would also receive regular health check-ups during the study. As this is a very early-stage study, the main risk is that the new treatment might cause unexpected side effects, some of which could be uncomfortable or, very rarely, more serious. The research team will explain all known potential risks in detail. Remember, your participation is completely voluntary, and 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
Germany

Common questions

What is 'mild allergic asthma'?

Mild allergic asthma means your asthma symptoms are usually mild and are often triggered by things you're allergic to, like pollen, dust, or pet dander.

What does a 'Human Pharmacology (Phase I)' study mean?

This is the very first time a new medicine is given to people. The main goal is to check how safe it is and how people's bodies react to it, rather than seeing if it cures a condition.

Will I get paid for taking part?

Some studies offer payment for your time and travel, but this varies. The study team will tell you if this is the case.

What is OM-85-IN?

OM-85-IN is the name of the new treatment being tested. It's an investigational medicine, meaning it's still being studied and is not yet available as a standard treatment.

Will my regular doctor know I'm in the study?

It's usually a good idea to tell your regular doctor you're thinking about joining a study, so they can advise you. The study team may also ask for your permission to inform your doctor.