Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Launched by TUNE THERAPEUTICS, INC. · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Tune-401 for adults with chronic Hepatitis B, a long-term liver infection caused by the hepatitis B virus (HBV). The main goals of the study are to check how safe Tune-401 is, how the body processes it, and how it affects the virus. The trial is currently looking for participants aged 18 to 75 who are diagnosed with chronic Hepatitis B and are already on a specific type of antiviral medication.

Eligible participants will receive Tune-401 and will be monitored closely throughout the study. This means they will have regular check-ups to ensure their safety and to gather important information about how well the treatment is working. It’s important to note that certain health conditions may prevent someone from joining the trial, such as high levels of liver enzymes or other liver diseases unrelated to hepatitis B. Overall, this study aims to contribute to new treatment options for those living with chronic Hepatitis B.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • M/F age 18-75, inclusive
• • Diagnosed with Chronic Hepatitis B
• • On nucleos(t)ide analogue
• • HBeAg-negative or positive
• • HBsAg \> 500 IU/ml
• • HBV DNA \< 90 IU/ml
• Exclusion Criteria:
• • ALT/ AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN
• • Participants with any evidence or history of liver disease of non-HBV etiology
• • Other protocol defined Inclusion/Exclusion criteria may apply