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

Trial Parameters

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Brief Summary

This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.

Eligibility Criteria

Inclusion Criteria: * M/F, BMI ≥ 18.5 kg/m² at screening, age 18-75, inclusive * Diagnosed with Chronic Hepatitis B * On nucleos(t)ide analogue * HBeAg-negative or positive 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

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