Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized, Double-Blind, Placebo-Controlled Phase IIa Trial to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of Repeated Subcutaneously Administered RBD4059 in Participants with Stable Coronary Artery Disease

This study is looking into a new treatment called RBD4059, given as an injection, for people who have a condition called stable coronary artery disease. This is a common heart problem where the main blood vessels supplying the heart become narrowed. The main goals are to make sure the new injection is safe and to understand how it works in the body. We'll be carefully watching for any side effects and checking how the body processes the medicine. We also want to see if it changes certain blood measurements linked to blood clotting, which is important for heart health. Participants will either receive the new injection or a dummy injection (placebo), along with their usual Trombyl medication. This is a Phase II study, which means it's an early stage but important step in developing new medicines.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ribocure Pharmaceuticals AB

Enrolment target

Start

27 May 2024

Stable Coronary Artery Disease

What is this study about?

This study is exploring a new medicine called RBD4059, which is given as an injection. It's designed for people who have 'stable coronary artery disease'. This condition means that the blood vessels that supply blood to your heart aren't working as well as they should, often because of a build-up inside them. Because it's 'stable', it means your symptoms are generally well-managed, but there's still a risk of future heart problems.

The main purpose of this study is to see if RBD4059 is safe for people to use and to understand how it behaves in the body. We'll be closely monitoring for any unwanted reactions, often called side effects. We also want to understand how the body absorbs, uses, and gets rid of the medicine. This helps us work out the best way to give the medicine in the future.

Beyond safety, we'll be looking at how RBD4059 affects certain things in your blood, particularly those related to blood clotting. Blood clots can be a concern in coronary artery disease, so understanding if this medicine influences them is very important. Participants will either receive the new medicine or a 'dummy' injection (a placebo) that looks just like the real thing, along with their usual heart medication. This comparison helps us tell if any changes we see are truly due to the new medicine or something else.

Key takeaways

This study tests a new injection for stable heart artery disease.
It aims to check safety and how the new medicine works in the body.
Participants will get either the new medicine or a dummy injection, plus their usual Trombyl.
Regular health checks, blood tests, and heart monitoring will be part of the study.
It's an early-stage study to gather important information for future treatments.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Crucially, you must have been diagnosed with 'stable coronary artery disease'. This means your heart condition is generally managed, and you're not having unstable or sudden heart problems right now. If your heart condition is not stable, this study would not be suitable for you.

There will also be other specific medical checks and tests to make sure that taking part in this study is safe and appropriate for your individual health situation. Your doctor will be able to tell you more about these detailed requirements.

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 a diagnosis of stable coronary artery disease?
Are you able to attend regular clinic visits?
Are you willing to potentially receive a dummy injection instead of the study medicine?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive either the new study injection (RBD4059) or a 'dummy' injection (placebo), along with your regular Trombyl medication. You wouldn't know which injection you're getting, and neither would your study doctor. This is done to make sure the results are as fair as possible.

You would have several visits to the clinic, where the study team would give you the injections and carry out various checks. These checks would include blood tests to look at how the medicine is working and to monitor your general health. They would also take your blood pressure and pulse (vital signs), perform physical examinations, and record your heart's electrical activity with an ECG (electrocardiogram). This would happen at each visit from the start of the study until the very end. The study will involve regular follow-up to make sure you remain safe and well. The exact number of visits and the full duration of your participation would be explained in more detail by the study team.

Potential risks and benefits

Participating in research studies like this can have potential benefits, such as contributing to new medical knowledge that could help others in the future. You might also receive careful medical attention and monitoring throughout the study. However, there are also potential risks; for instance, you might experience side effects from the study medication, though these will be closely monitored. The 'dummy' injection contains a small amount of vitamin B2, which could cause a temporary yellow colour, but otherwise it's harmless. It's important to remember that 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.

—
Unverified
Sweden

Common questions

What is 'stable coronary artery disease'?

It's a common heart condition where the blood vessels supplying your heart are narrowed, but your symptoms are generally stable and managed.

What is RBD4059?

It's a new medicine being tested as an injection to see if it's safe and how it affects blood markers related to heart health.

What is a 'placebo'?

A placebo is a 'dummy' injection that looks exactly like the study medicine but contains no active drug. It helps researchers compare the effects of the real medicine.

Will I still take my regular heart medicine?

Yes, if you participate, you will continue taking your Trombyl 75 mg tablets as prescribed.

What does a 'Phase II' study mean?

Phase II means it's an early but important stage of testing a new medicine. We're looking at its safety and how it works in a small group of people.