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

January 2, 2026 updated by: Tune Therapeutics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital, University of Hong Kong
        • Contact:
          • Man Fung Yuen
        • Principal Investigator:
          • Man Fung Yuen, MD
  • Moldova
      • Chisinau, Moldova, MD2025
        • Recruiting
        • PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit
        • Principal Investigator:
          • Alina Jucov
  • New Zealand
      • Auckland, New Zealand, 1010
        • Recruiting
        • New Zealand Clinical Research
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tune-401 Part I : Single Ascending Dose
Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
Genetic: Tune-401
Epigenetic gene silencing therapy
Experimental: Tune-401 Part II :Single/Finite Multiple Dose
Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
Genetic: Tune-401
Epigenetic gene silencing therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as assessed by treatment emergent adverse events
Time Frame: 20 weeks
Number of participants with treatment-related adverse events (TEAEs)
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Long-term safety
Time Frame: 104 weeks
Number of participants with TEAEs ( safety laboratory tests (hematology, biochemistry, coagulation parameters, and urinalysis) and vital signs of clinical significance)
104 weeks
Tune-401 Pharmacokinetics (Cmax)
Time Frame: 8 weeks
Maximum concentration (Cmax)
8 weeks
Tune-401 Pharmacokinetics (Tmax)
Time Frame: 8 weeks
Time it takes to reach Cmax (Tmax)
8 weeks
Tune-401 Pharmacokinetics (AUC)
Time Frame: 8 weeks
Extrapolated area under the concentration-time curve (AUC-infinity)
8 weeks
Tune-401 Pharmacokinetics (CL)
Time Frame: 8 weeks
Clearance (CL)
8 weeks
Tune-401 Pharmacokinetics (half-life)
Time Frame: 8 weeks
Terminal half-life (t½)
8 weeks
Tune-401 Pharmacokinetics (Vd)
Time Frame: 8 weeks
Volume of distribution (Vd)
8 weeks
Tune-401 Pharmacodynamics
Time Frame: 104 weeks
Changes from baseline in HBsAg
104 weeks
Tune-401 Immunogenicity
Time Frame: 104 weeks
Development of anti-Tune-401 antibodies
104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tune Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2024

Primary Completion (Estimated)

June 28, 2028

Study Completion (Estimated)

October 30, 2028

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 31, 2024

First Posted (Actual)

November 4, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tune-401-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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