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

Study on the investigational drug IAMA-6, placebo-controlled, administered to healthy adult volunteers, at single oral doses and at multiple ascending oral doses to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of IAMA-6 and its interaction with food

This study is an early investigation into a new medicine, called IAMA-6. It's being given to healthy adult volunteers for the first time. The main goals are to check if the medicine is safe and if people can tolerate it well. Researchers will also be looking at how the body absorbs, uses, and gets rid of IAMA-6, and how taking it with or without food might change these effects. This information is a crucial first step before the medicine can be tested in people who might benefit from it for conditions like neurodevelopmental disorders. It helps us understand the medicine better before it moves to larger studies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Iama Therapeutics S.r.l.

Enrolment target

Start

19 Dec 2023

Neurodevelopmental disorder

What is this study about?

Imagine scientists have developed a brand new key. Before they can try that key in a lock they hope to open, they need to make sure the key itself is safe to handle and understand how it works. That's a bit like what this study, called a Phase I trial, is all about for the new medicine IAMA-6.

Researchers are giving this medicine to healthy adult volunteers. This means people who don't have the health condition the medicine is eventually meant to treat. The main reason for this is to carefully check if the medicine is safe and doesn't cause too many side effects when given for the very first time to humans. They'll also be trying different amounts of the medicine to see what doses are safe and how much the body can handle without problems.

Beyond safety, the study will also look at how your body handles IAMA-6. This includes how long it stays in your system, how much is absorbed, and how it's processed and removed. They'll even check if eating food makes a difference to how your body deals with the medicine. All this information is really important because it helps scientists decide if it's safe to continue testing IAMA-6 in people who actually have neurodevelopmental disorders, and ultimately, whether it could become a helpful treatment in the future.

Key takeaways

This is a very early study of a new medicine called IAMA-6.
It's primarily looking at safety and how the body handles the medicine.
Only healthy adults aged 18 and over can participate.
Some volunteers will receive the medicine, others a dummy pill (placebo).
Participation will involve regular clinic visits and health checks.

Who may be eligible?

To join this study, called a trial, you need to be an adult, at least 18 years old. People of any gender can take part.

Since this is an early safety study, it's open only to healthy volunteers. This means you generally shouldn't have any major ongoing health problems or be taking a lot of regular medication that might interfere with the new test medicine. The doctors and nurses running the study will do a thorough check-up to make sure you're suitable.

They are looking for people who are generally healthy and available to commit to the study schedule. Specific details about who can and cannot join will be explained fully by the study team, as each person's health situation is unique.

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 consider yourself generally healthy?
Are you able to commit to several clinic visits?
Are you willing to potentially receive a new, untested medicine or a placebo?
Are you comfortable with having regular medical checks and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the investigational medicine IAMA-6, or possibly a placebo (a dummy medicine with no active ingredients). This is usually given as a single dose first, then possibly as multiple doses over time, depending on the study design. You would have regular check-ups and medical tests, which might include blood samples and health exams, to monitor your safety and how your body reacts to the medicine. The study team will explain the exact number of visits, how long each visit might be, and the total duration of your involvement in the study. You'll have a clear schedule of when you need to come to the clinic for assessments and to receive the medicine, and when you'll have follow-up checks after your doses.

Potential risks and benefits

Taking part in this study could help us learn more about IAMA-6, which might eventually lead to new treatments for neurodevelopmental disorders, though you personally won't directly benefit from the medicine itself in this early stage. As with any new medicine, there's always a chance of side effects, some of which might be unexpected or unpleasant. The study team will monitor you very closely for any problems. You have the right to leave 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
Italy

Common questions

What is a 'neurodevelopmental disorder'?

These are conditions that affect how the brain grows and develops, which can impact things like learning, communication, and behaviour.

Why is this study only for 'healthy adult volunteers'?

In the very first stage of testing a new medicine, it's important to see if it's safe and how the body handles it in people who are otherwise well, before giving it to people who are unwell.

What does 'placebo-controlled' mean?

It means some people will get the active medicine IAMA-6, and others will get an inactive dummy pill (placebo). This helps researchers see if any effects are truly from the medicine or just a coincidence.

What is a 'Phase I' study?

Phase I is the first step in testing a new medicine in humans. It focuses mainly on safety, finding a safe dose, and understanding how the body processes the medicine.

Will I know if I'm getting the medicine or the placebo?

Usually, in a placebo-controlled study, neither you nor the study team will know who is receiving which until after the study is over. This helps keep the results fair and unbiased.