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RECRUITINGPhase 1NCT06671093

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

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.

Lead sponsor: Tune Therapeutics, Inc.•3 locations•View source on ClinicalTrials.gov

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Contacts

Tune Therapeutics, Inc.

CONTACT

855 755 8863 clinical.operations@tunetx.com

Sponsors

Lead Sponsor

Tune Therapeutics, Inc.

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.

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 6, 2026Terms

Trial snapshot

StatusRECRUITING

PhasePHASE1

Enrollment36

Start dateNov 2024

Last updatedJan 6, 2026

Condition

Chronic Hep B Chronic Hepatitis b Chronic Hepatitis HBV

Locations shown

Queen Mary Hospital, University of Hong Kong

Hong Kong

PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit

Chisinau

New Zealand Clinical Research

Auckland

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 6, 2026Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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