Badanie nad skutecznością i bezpieczeństwem RBD1016 u pacjentów z przewlekłym wirusowym zapaleniem wątroby typu B na tle leczenia analogami nukleozydów

Chronic Hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. This study is focused on evaluating a new treatment called RBD1016 injection for people with this condition. The study aims to assess how safe and effective this treatment is when used alongside existing medications known as nucleoside analogues, which are commonly used to manage chronic hepatitis B.

The study is structured into several phases, including a screening period, a treatment period, and a follow-up period. Participants will be divided into different groups to receive varying doses of the RBD1016 injection or a placebo. The doses will be administered either every four weeks or every twelve weeks. In total, 36 participants will receive the RBD1016 injection, while 12 participants will receive a placebo. The study will monitor the safety of the treatment by observing any side effects and will also measure the effectiveness by checking changes in the levels of the virus in the body.

The main goal of the study is to determine if the RBD1016 injection can safely reduce the amount of the hepatitis B virus in the body and improve liver health. Participants will be closely monitored throughout the study to ensure their safety and to gather information on how the treatment affects the virus and the immune system. The study is expected to continue until the end of 2025.