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

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-101 Following Oral Administration in Healthy and Chronic Hepatitis B Subjects

This study is about a new medicine called AB-101 for people who have long-term hepatitis B, as well as healthy volunteers. It's a very early-stage trial, meaning it's the first time this medicine is being given to humans. The main goal is to check if AB-101 is safe and well-tolerated. Researchers will also look at how much of the medicine gets into the body, how long it stays there, and how the body breaks it down. They also want to see if it starts to have an effect on the body, which could be important for treating hepatitis B. This type of study is crucial for developing new treatments for serious conditions like hepatitis B.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Arbutus Biopharma Inc.

Enrolment target

Start

04 Dec 2024

Chronic hepatitis B virus Infection

What is this study about?

This research study is looking at a new medicine, called AB-101, for people who have chronic hepatitis B. Chronic hepatitis B means you've had the hepatitis B virus in your body for a long time. The study is also open to healthy volunteers who do not have hepatitis B. This is a very early study, often called a 'Phase I' trial. This means it's the very first time this new medicine is being given to people, either healthy individuals or those with the condition it's designed to treat.

The main reasons for doing this study are to make sure the medicine is safe and that people can take it without too many problems. The researchers will be carefully watching for any side effects. They also want to understand how the medicine moves through your body, how much of it reaches your bloodstream, how long it stays there, and how your body gets rid of it. This helps them work out the best dose to use in future studies.

Finally, the study will also look to see if the medicine starts to have any effect on the body, especially in people with hepatitis B. While it's too early to expect a cure, any early signs of the medicine working are important. This type of study is a vital first step in developing new medicines to help people with conditions like chronic hepatitis B.

Key takeaways

This is an early-stage study (Phase I) for a new medicine called AB-101.
It's the first time AB-101 is being given to people.
The main goals are to check the medicine's safety and how the body handles it.
Participants can be healthy volunteers or people with chronic hepatitis B.
You must be at least 18 years old to take part.
Participation involves taking the medicine and attending clinic visits for tests.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There isn't an upper age limit mentioned, so older adults might also be able to participate. Both men and women can take part in this research.

When you're being considered, the research team will ask you some detailed questions about your health and medical history. This is to make sure the study is a good fit for you and that taking part would be safe. For example, if you have chronic hepatitis B, they will check specific aspects of your condition.

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, or are you a healthy adult?
Are you able to attend regular clinic visits?
Are you comfortable taking a new, experimental medicine?
Are you a man or a woman?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given the new medicine called AB-101 orally, meaning you'll take it by mouth, likely as a pill or liquid. You'll have several visits to the clinic, which will involve medical checks, blood tests, and possibly other tests to monitor how your body is reacting to the medicine and how it's affecting your hepatitis B (if you have it).

The study will involve regular follow-up appointments to keep track of your health and any effects of the medicine. The total duration of your participation, including all visits and follow-ups, will be clearly explained to you before you agree to join. You'll receive full details about the schedule from the research team.

Potential risks and benefits

There are no definite benefits to you from participating in an early-stage study like this, as its main purpose is to test the safety of a new medicine. However, you would be helping medical science learn more about potential new treatments for hepatitis B. There are always potential risks when taking a new medicine for the first time. Side effects are possible, and some might be serious. The research team will explain all known and potential risks. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Romania
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Unverified
Italy
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Unverified
Bulgaria

Common questions

What is chronic hepatitis B?

Chronic hepatitis B means you have the hepatitis B virus in your body for a long time, which can sometimes lead to serious liver problems over many years.

What does 'Phase I' mean?

Phase I means this is the very first time this new medicine is being given to people. The main goal is to check its safety and how the body handles it.

Will I get paid to participate?

The study information doesn't say if participants will be paid, but often early-stage trials offer some payment or cover travel expenses. You should ask the study team.

What is AB-101?

AB-101 is the name of the new experimental medicine being tested in this study. It's designed to treat chronic hepatitis B.

Are there other treatment options for hepatitis B?

Yes, there are existing treatments for chronic hepatitis B, but this study is trying to find new and potentially better options. Your doctor can discuss current treatments with you.