Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase II clinical trial to evaluate the safety, efficacy, and pharmacokinetics of RBD1016 injection in participants with chronic hepatitis B

This study is a Phase II clinical trial looking into a new treatment called RBD1016 for people with long-term hepatitis B. The main goals are to find out how safe the medicine is by tracking any side effects, and how effective it is at reducing the amount of the hepatitis B virus in the body. We're also studying how the body handles the medicine. The medicine, RBD1016, is given as an injection under the skin. It comes as a clear, light yellow liquid. The yellow colour is from a tiny amount of vitamin B2, which is harmless and doesn't affect the medicine. This research will help us understand if RBD1016 could be a good treatment option for chronic hepatitis B in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Suzhou Ribo Life Science Co. Ltd.

Enrolment target

Start

17 May 2023

Chronic hepatitis B

What is this study about?

This research is a Phase II clinical trial, which means it's an early-stage study to learn more about a new medicine called RBD1016. The medicine is being tested for people who have chronic hepatitis B, a long-term infection of the liver caused by the hepatitis B virus. The main aims of the study are to check if the medicine is safe to use, how well it works to reduce the virus, and how the body processes it.

For safety, we'll be watching closely for any side effects, whether they are minor or more serious. To see how well the medicine works, we'll measure changes in a specific marker linked to the hepatitis B virus called HBsAg. We want to see if the level of HBsAg goes down after people receive the treatment. We will also learn more about how the body absorbs, uses, and gets rid of the medicine.

The new medicine, RBD1016, is given as an injection under the skin. It looks like a clear, light yellow liquid. The light yellow colour comes from a very small amount of vitamin B2, which is just for colouring and doesn't have any active effect on the body at this low level. This study is an important step to see if RBD1016 could become a new treatment option for people living with chronic hepatitis B.

Key takeaways

This study is testing a new medicine called RBD1016 for chronic hepatitis B.
It's a Phase II trial, so we're looking at safety and how well the medicine works.
The medicine is given as an injection under the skin.
Researchers will check for side effects and how much the virus marker (HBsAg) changes.
Participation involves regular clinic visits for checks and blood tests.

Who may be eligible?

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

Beyond these basic requirements, there will be other important health checks to make sure the study is a good fit for you and that it's safe for you to take part. This will involve reviewing your medical history and current health.

Things like other health conditions you might have, medicines you are currently taking, or specific results from blood tests could affect whether you can participate. The study team will discuss all these details with you to see if you meet all the specific criteria.

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 chronic hepatitis B?
Are you able to attend regular clinic appointments?
Are you currently taking any medicines that might affect your participation?
Do you have any other significant health conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, RBD1016, as an injection under your skin. The study team would show you how or give you these injections regularly. You would have several visits to the clinic for health checks, blood tests, and to make sure you're feeling okay and the medicine is working as expected. These visits would also be used to track any side effects you might experience.

The study would involve regular follow-up appointments for at least 24 weeks after you start the treatment. During these follow-up visits, we would continue to check your health and how the medicine has affected your body. In total, the study participation would last for several months, including both the treatment period and the follow-up period.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as access to a new treatment that isn't yet widely available, which could potentially help manage your chronic hepatitis B. However, there are also potential risks, including side effects from the study medicine, which we will monitor very closely. It's important to remember that this is an early study, and we don't yet know if the medicine will be effective for everyone, or what all the potential side effects might be. You have the right to leave 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.

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Unverified
Sweden

Common questions

What is chronic hepatitis B?

Chronic hepatitis B is a long-term liver infection caused by the hepatitis B virus. It can cause serious health problems over time if not managed.

What is a Phase II clinical trial?

It's an early stage of testing a new medicine. We're looking to see if it's safe, if it works, and what doses to use, before it's tested in even more people.

What is RBD1016?

RBD1016 is a new medicine being developed to treat chronic hepatitis B. It's given as an injection under the skin.

What does 'HBsAg decline' mean?

HBsAg is a marker of the hepatitis B virus in your blood. A 'decline' means the level of this marker is going down, which suggests the medicine might be reducing the virus.

Will I get the actual medicine or a dummy injection?

This study is testing the new medicine, RBD1016. In Phase II studies, participants typically receive the active drug, but the study team will explain the exact details.