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

RECRUITINGPHASE1

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

Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection

NCT06671093•Tune Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Detailed 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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (3)

Queen Mary Hospital, University of Hong Kong

Hong Kong, Hong Kong

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

Chisinau, Moldova

New Zealand Clinical Research

Auckland, New Zealand

Key Dates

Start Date

November 29, 2024

Primary Completion Date

June 28, 2028

Completion Date

October 30, 2028

Last Updated

January 6, 2026

Enrollment

ESTIMATED participants

Conditions

Chronic Hep BChronic Hepatitis bChronic HepatitisHBV

Interventions

Tune-401

GENETIC

Contacts

Tune Therapeutics, Inc.

CONTACT

855 755 8863 clinical.operations@tunetx.com

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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: March 29, 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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Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Inclusion Criteria

Exclusion Criteria

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