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

A first-in-human, randomized, participant and investigator blinded, placebo-controlled single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of HJB647 in healthy participants and otherwise healthy participants with elevated blood pressure, with an open-label CYP3A inhibitor drug-drug interaction part

This is an early-stage medical study, often called a Phase 1 trial, and it's the very first time this new medicine, HJB647, is being given to people. The main goals are to check if HJB647 is safe to use and how your body processes it. We are studying both healthy volunteers and people who are generally healthy but have been told they have slightly high blood pressure. Everyone involved, including the participants and the doctors, won't know if they are receiving HJB647 or a dummy medicine (placebo) until the study ends. This helps make the results fair. We're also doing a special part of the study to see how HJB647 interacts with another common medicine that affects how the body breaks down drugs. This research is important for understanding potential new treatments for conditions like heart failure.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Novartis Pharma AG

Enrolment target

106

Start

20 Nov 2023

Heart failure (HF)

What is this study about?

This study is an important first step in understanding a new medicine called HJB647. It's what we call a 'first-in-human' study, meaning it's the very first time this particular drug is being given to people. The main purpose is to make sure it's safe and to learn how your body handles the medicine, for example, how much stays in your system and for how long. We'll be giving different doses to see what happens as the amount increases.

To make sure the study results are as clear and unbiased as possible, neither you nor the doctors will know if you're receiving the actual medicine, HJB647, or a 'dummy' treatment called a placebo. A placebo looks just like the real medicine but contains no active drug. This helps us accurately see the effects of HJB647. Some participants will be healthy volunteers, while others will be healthy but have slightly raised blood pressure. This allows us to see how the medicine works in slightly different groups of people.

There's also a specific part of the study where we'll look at how HJB647 might interact with another common medicine that affects how your body processes drugs. This is crucial because many people take more than one medicine, and doctors need to know if new drugs will work safely alongside existing ones. Although the study is about a new medicine that could eventually help with conditions like heart failure, this very early stage is focused purely on safety and how your body reacts to the drug, not on treating heart failure itself.

Key takeaways

This is an early-stage study testing a new medicine (HJB647) for the first time in people.
The main goals are to check the medicine's safety and how your body handles it.
Participants will include healthy volunteers and healthy people with slightly high blood pressure.
Neither you nor the doctors will know if you're taking the real medicine or a dummy pill (placebo).
The study also looks at how HJB647 interacts with another common medicine.
Participation will involve clinic visits, taking study medicine, and regular health checks.

Who may be eligible?

To join this study, you generally need to be an adult, 18 years old or older. Both men and women are welcome to take part. Researchers are looking for people who are otherwise healthy.

Some healthy people will be included, and also people who are generally healthy but happen to have slightly high blood pressure. They want to see how the new medicine works in both groups.

There will be other detailed health checks to make sure the study is safe for you and that the results are reliable. For example, you might not be able to join if you have certain existing health conditions or take specific medications that could interfere with the study medicine.

Quick self-check

Are you 18 years old or older?
Are you generally healthy, or generally healthy with slightly high blood pressure?
Are you able to attend several clinic visits?
Are you willing to potentially take a new, untested medicine or a placebo?
Are you not currently pregnant or breastfeeding (if applicable)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll visit the study clinic several times. During these visits, the study team will carry out various checks, like blood tests, urine tests, and monitoring your heart. You'll be given either the new medicine, HJB647, or a placebo (a dummy medicine) to take. Initially, you might take a single dose, and then later, some participants will take it for a longer period to see what happens with repeated doses. There will also be follow-up appointments after you stop taking the medicine to make sure you're well. The total time you'd be involved in the study, from your first visit to your last follow-up, can vary.

Potential risks and benefits

Taking part in a study like this always has potential benefits and risks. A potential benefit is contributing to medical science, which could help develop new ways to treat serious conditions like heart failure in the future. You will also receive careful medical monitoring throughout the study. However, there are also risks, as this is a new medicine being given to people for the first time. You might experience side effects, some of which may be unknown. There's also no guarantee that the medicine will help you personally. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What does 'first-in-human' mean?

It means this is the very first time the new medicine, HJB647, is being given to people to test its safety.

Will I know if I'm getting the real medicine or a dummy pill?

No, neither you nor the study doctors will know if you're getting HJB647 or a placebo until the study is over, to keep the results fair.

Why include people with high blood pressure?

They want to see how the medicine affects people who are generally healthy but have slightly high blood pressure, alongside healthy volunteers.

What is 'pharmacokinetics'?

This refers to understanding how your body handles the medicine – how it absorbs, distributes, breaks down, and gets rid of the drug.

Will this study treat my heart condition?

No, this early-stage study is focused on safety and how the body handles the medicine, not on treating heart conditions like heart failure.