Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A SINGLE-CENTER, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF REPEAT DOSES OF ARM210 IN HEALTHY SUBJECTS.

This clinical trial is designed to investigate a new medicine called ARM210, which aims to help with heart rhythm problems (cardiac arrhythmias). This is an early-stage study, meaning it's one of the first times this medicine is being tested in people. We'll be giving repeat doses of ARM210 to healthy volunteers, not people with heart conditions. The main goals are to make sure the medicine is safe, see if people experience any side effects (how well they tolerate it), and understand how the body processes the medicine after several doses. This information is crucial for deciding if the medicine can be tested further in patients who might benefit from it.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Armgo Pharma Inc.

Enrolment target

Start

02 Feb 2024

Cardiac arrhythmias

What is this study about?

Imagine your heart doing a little dance, sometimes too fast, sometimes too slow, or just out of rhythm. This is what we call a heart rhythm problem. Scientists are always trying to find new ways to help hearts beat normally again, and this study is about one such new medicine, called ARM210.

This particular study is a very early step in testing ARM210. Think of it like taking a brand-new car for its first few test drives. We're not yet testing it on rough roads, but rather on smooth, controlled tracks. In this case, the 'track' is healthy volunteers – people who don't have heart problems. The main reason for this is to make sure the medicine is safe and doesn't cause unexpected problems before we even consider giving it to people who are unwell.

We also want to see how your body handles the medicine over time. Does it stay in your system for a long time, or does it leave quickly? Does taking it repeatedly change how your body reacts? Understanding these things helps scientists work out the best amount of medicine to give and how often. All this helps them decide if ARM210 could be a helpful treatment for heart rhythm problems in the future.

Key takeaways

Tests a new medicine, ARM210, for heart rhythm problems.
First time ARM210 is given repeatedly to healthy people.
Aims to check safety, side effects, and how the body handles the medicine.
Participants will be healthy adults.
You might receive the new medicine or a dummy pill (placebo).
Participation helps advance medical research.

Who may be eligible?

To join this study, you need to be a healthy adult. This means you shouldn't have any major ongoing health problems, especially not heart conditions. The study team will do a thorough health check to make sure you're suitable.

If you're under 18 years old, you won't be able to take part. The study is open to both men and women. The doctor will also check if any other health issues or medicines you take might affect the results or your safety in the study.

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 do not have any serious ongoing medical conditions?
Do you not have any known heart rhythm problems?
Are you available for regular clinic visits and follow-ups?
Are you willing to potentially receive a placebo instead of the study medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be one of a small group of healthy volunteers. You might receive the new medicine, ARM210, or a placebo (a dummy medicine with no active ingredients, like a sugar pill) – you won't know which one. You'll take the medicine (or placebo) repeatedly over a set period. During this time, you'll have regular visits to the clinic, where doctors and nurses will monitor your health closely. This will involve checks like blood tests, heart readings (ECGs), and answering questions about how you're feeling. They'll also check for any side effects. After you finish taking the medicine, there will be follow-up visits to make sure you're still well. The total time you'd be involved in the study, from start to finish, would be explained to you in detail.

Potential risks and benefits

The main benefit of taking part in any early-stage study is helping advance medical knowledge, which could lead to new treatments for others in the future. For you personally, there isn't a direct health benefit as you are healthy. Potential risks include side effects from the new medicine, which could range from mild discomfort to more serious reactions. You would be closely monitored for these. 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 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 a 'healthy subject' in this study?

A 'healthy subject' means someone who does not have any major ongoing health problems, especially not heart conditions, and is generally well.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks just like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine.

Will I definitely get the new medicine?

No, you might receive the new medicine (ARM210) or the placebo. This helps us objectively understand the medicine's effects.

How long will the study participation last?

The total duration of your involvement, including all visits and follow-ups, will be clearly explained before you agree to take part.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason. Your decision will not affect your future medical care.