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

Last updated: January 24, 2025
Sponsor: Tune Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Hepatitis

Hepatitis B

Hepatitis C; Chronic

Treatment

Tune-401

Clinical Study ID

NCT06671093
Tune-401-001
  • Ages 18-75
  • All Genders

Study 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

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

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 Design

Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Tune-401
Phase: 1
Study Start date:
November 29, 2024
Estimated Completion Date:
October 30, 2028

Study Description

This study consists of an open-label, single-ascending dose phase, which will identify the dose for evaluation in a cohort expansion. The expansion phase will be open-label to further characterize the activity of Tune-401 on PD parameters and obtain additional safety data.

Connect with a study center

  • Queen Mary Hospital, University of Hong Kong

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • New Zealand Clinical Research

    Auckland, 1010
    New Zealand

    Active - Recruiting

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