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NCT Number: NCT06671093

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.

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Key information

Conditions

Chronic Hep B Blood-Borne Infections Chronic Disease Chronic Hepatitis Chronic Hepatitis B Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes HBV Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Queen Mary Hospital, University of Hong Kong, Hong Kong

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tune-401

Genetic

Epigenetic gene silencing therapy

Primary outcomes

  1. Safety as assessed by treatment emergent adverse events

    Time frame: 20 weeks

    Number of participants with treatment-related adverse events (TEAEs)

Secondary outcomes

  1. 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)

  2. Tune-401 Pharmacokinetics (Cmax)

    Time frame: 8 weeks

    Maximum concentration (Cmax)

  3. Tune-401 Pharmacokinetics (Tmax)

    Time frame: 8 weeks

    Time it takes to reach Cmax (Tmax)

  4. Tune-401 Pharmacokinetics (AUC)

    Time frame: 8 weeks

    Extrapolated area under the concentration-time curve (AUC-infinity)

  5. Tune-401 Pharmacokinetics (CL)

    Time frame: 8 weeks

    Clearance (CL)

  6. Tune-401 Pharmacokinetics (half-life)

    Time frame: 8 weeks

    Terminal half-life (t½)

  7. Tune-401 Pharmacokinetics (Vd)

    Time frame: 8 weeks

    Volume of distribution (Vd)

  8. Tune-401 Pharmacodynamics

    Time frame: 104 weeks

    Changes from baseline in HBsAg

  9. Tune-401 Immunogenicity

    Time frame: 104 weeks

    Development of anti-Tune-401 antibodies

Study contacts

Contact information is provided by the study sponsor or research team.

Tune Therapeutics, Inc.

CONTACT

[email protected]

855 755 8863

Sponsors and collaborators

Lead sponsor

Tune Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 4, 2024
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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