AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A study understanding how much CDR132L enters the bloodstream after injection under the skin compared to injection into a vein in healthy participants

This clinical study is designed to understand how a new medicine called CDR132L moves through the body. We're comparing two ways of giving it: as an injection just under the skin (like a vaccine) versus an injection directly into a vein (into the bloodstream). We want to see how much of the medicine gets into the blood and how quickly, depending on how it's given. This information is important for future studies where CDR132L might be used to treat heart failure. For this early stage, we need healthy volunteers to help us learn more about the medicine's behaviour in the body.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Novo Nordisk A/S

Enrolment target

Start

26 Jan 2026

Healthy volunteers treatment for heart failure

What is this study about?

This study is about a new medicine called CDR132L. Before a medicine can be used to treat illnesses like heart failure, doctors need to understand how it behaves in the human body. One of the first things they need to find out is how well the medicine gets into the bloodstream and how much of it reaches the target areas.

In this study, we are specifically looking at two ways of giving CDR132L. One way is by injecting it just under the skin, which is often called a 'subcutaneous' injection – a bit like an insulin jab or some vaccinations. The other way is by injecting it directly into a vein, which is called an 'intravenous' injection. We want to compare these two methods to see if the medicine gets into the blood and works the same way regardless of how it's given. This helps researchers figure out the best and most convenient way to give this medicine to patients in the future.

Even though CDR132L is planned for treating heart failure, this very early study involves healthy volunteers. This is typical for the first steps of testing a new medicine. By studying it in healthy people, researchers can safely learn how the medicine acts in the body without the complications of an illness like heart failure. This information is crucial for understanding how the medicine might work and how best to give it to patients later on.

Key takeaways

This study is testing how a new medicine, CDR132L, gets into the body.
It compares giving the medicine under the skin versus into a vein.
Healthy adult volunteers are needed for this early-stage research.
The information learned helps doctors understand the best way to give this medicine in the future.
CDR132L is being developed as a potential treatment for heart failure.

Who may be eligible?

To take part in this study, you need to be a healthy adult aged 18 or older. This means you generally don't have any major ongoing health problems or serious illnesses. The study needs to ensure that only the medicine itself is affecting results, and not any other health issues.

Both men and women are welcome to participate. Being healthy means you would likely not be taking many regular medications and would not have conditions that might interfere with how the study medicine works or how your body handles it. The research team will carefully check your health to make sure you are suitable and that it's safe for you to take part.

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?
Do you have any serious ongoing medical conditions?
Are you able to commit to several clinic visits and possibly overnight stays?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, CDR132L, on different occasions, sometimes as a jab under your skin and sometimes into a vein. Doctors and nurses would be there to look after you. You would have several health checks, blood tests, and possibly other tests to see how the medicine is affecting your body and how much of it is in your blood. There will be multiple visits to the clinic, and possibly some overnight stays, especially after you've received the medicine, so the doctors can closely monitor you. The entire study duration, including all visits and follow-ups, would be explained to you fully.

Potential risks and benefits

Participating in research can directly help others by contributing to new medical knowledge. While you might not personally benefit directly from this study, the information gained is vital for developing potential new treatments for heart failure. Like all medicines and medical procedures, there can be potential risks. You might experience common side effects like soreness or bruising where injections are given, or other mild reactions. More serious side effects are possible but rare, and the study team will monitor you closely. You are free 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
Germany

Common questions

What is CDR132L?

CDR132L is a new medicine that researchers are studying. It's hoped that one day it might be used to help people with heart failure, but this study is an early step to understand it better.

Why do you need healthy volunteers?

For this very first study in humans, using healthy volunteers helps researchers understand how the medicine behaves in the body without the complexities of other illnesses. It’s a safe way to start learning about the medicine.

What's the difference between 'under the skin' and 'into a vein' injections?

An injection 'under the skin' (subcutaneous) is a bit like an insulin shot. An injection 'into a vein' (intravenous) goes directly into your bloodstream, usually in your arm.

Will I get the medicine for heart failure in this study?

No, this study is about understanding how the medicine works in the body, not about treating heart failure yet. You need to be a healthy volunteer to take part in this particular study.

How long would I need to be involved?

The full details of how long you'd be involved, including clinic visits and follow-ups, would be explained by the study team. It will involve several visits, and possibly some overnight stays.