A Phase 1, Double-blind, Randomized, Placebo-controlled, First-in-Human Study of Orally Administered DF-006 to Evaluate the Safety, Tolerability, and Pharmacokinetics After a Single Dose and Multiple Doses of Orally Administered DF-006 in Healthy Subjects (Part 1 and Part 2) and in Chronic Hepatitis B Patients (Part 3). Protocol Number Df-006-1001
This research is looking into a new treatment called DF-006 for chronic hepatitis B. It's an early-stage study, meaning it's one of the first times this medicine is being given to people. Researchers want to understand if DF-006 is safe and how well people can tolerate it, both after a single dose and when taken over a longer period. They will also look at how the body processes the medicine. The study will involve healthy volunteers first, and then people who have chronic hepatitis B. This type of study is crucial for seeing if new medicines are promising enough to continue testing.
At a glance
What is this study about?
Imagine you have a long-term problem like chronic hepatitis B, and doctors are always searching for better ways to help. That's exactly what this study is about. Researchers are trying a brand-new medicine, which for now is just called DF-006, to see if it could eventually become a new treatment option.
This is a very early-stage study, often called a 'Phase 1' study. Think of it like taking a new car design out for its very first test drive. The main goals at this stage are not to cure the condition, but to carefully check a few important things: Is this new medicine safe for people to take? Does it cause unwanted side effects? And how does your body handle the medicine once you've taken it – how long does it stay in your system, for example?
Because this is such an early step, the study will involve different groups. First, healthy volunteers will take the medicine, as this helps researchers understand its basic effects without other health issues getting in the way. Then, people living with chronic hepatitis B will be invited to take part, allowing doctors to see how their bodies react specifically. This careful approach helps ensure safety as they learn more about DF-006.
Key takeaways
- Tests a new medicine (DF-006) for chronic hepatitis B.
- Early-stage study focused on safety and how the body handles the medicine.
- Involves healthy volunteers and people with chronic hepatitis B.
- Participants will receive either the medicine or a dummy pill.
- Close medical monitoring and regular health checks are part of participation.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study welcomes both men and women.
Initially, they will be looking for healthy volunteers. This means people who don't have any major medical conditions and are generally well. Once they've gathered enough information from healthy people, the study will then open up to individuals who have been diagnosed with chronic hepatitis B.
There will be specific health checks and rules to make sure the study is safe for everyone involved. For example, some existing health conditions or medicines you're taking might mean you can't join. The study team will review your medical history carefully to see if it's right for you.
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 (or are you willing to be) a generally healthy person?
- Or, do you have a diagnosis of chronic hepatitis B?
- Are you able to attend regular clinic visits?
- Are you willing to discuss your full medical history with the study team?
What does participation involve?
If you decide to take part in this study, you would first have health checks to make sure it's safe for you. This might involve blood tests, physical exams, and answering questions about your health. If you are suitable, you would then receive the study medicine, DF-006, or a placebo (a dummy pill with no active medicine) for a set period. You wouldn't know which one you're getting, and neither would the doctors, to keep the results fair.
Your participation would involve several visits to the study clinic. During these visits, the study team would closely monitor your health, take more blood and urine samples, and ask about any side effects you might be experiencing. They would also check how much of the medicine is in your body over time. The total length of your participation, including follow-up appointments after you stop taking the medicine, would be explained fully before you join.
Potential risks and benefits
Locations (2)
- —UnverifiedRomania
- —UnverifiedBulgaria
Common questions
What is chronic hepatitis B?
Chronic hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. It can cause serious liver problems over time.
What does 'Phase 1' mean?
Phase 1 means this is one of the very first times the medicine is being tested in people. The main goal is to check its safety and how the body handles it.
Will I get the actual medicine or a dummy pill?
Some people in the study will get the new medicine (DF-006), and others will get a placebo (a dummy pill with no active medicine). You won't know which one you're getting.
How long will I be in the study?
The exact length of time will be clearly explained by the study team. It will involve taking the medicine and follow-up visits.
Who is running this study?
This study is sponsored by a particular research company, and it follows strict rules set by health authorities to ensure patient safety.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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