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

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

Recruiting
18-75 years
All
Phase 1
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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.

Description

This study consists of an open-label, Part I single-ascending dose phase and Part II single and finite multiple dose phase to characterize the activity of Tune-401 on PD parameters and obtain safety data.

Eligibility

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

Study details
    Chronic Hep B
    Chronic Hepatitis b
    Chronic Hepatitis
    HBV

NCT06671093

Tune Therapeutics, Inc.

16 October 2025

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