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Recruiting NCT06671093

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

Phase I Interventional Chronic Hep B Chronic Hepatitis b Chronic Hepatitis HBV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tune-401.
Who it may be relevant to
Registry conditions: Chronic Hep B, Chronic Hepatitis b, Chronic Hepatitis, HBV. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong, Moldova, New Zealand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Genetic Tune-401
    Epigenetic gene silencing therapy

Primary outcome measures

  • Safety as assessed by treatment emergent adverse events [Time frame: 20 weeks]
Secondary outcome measures (9)
  • Long-term safety [Time frame: 104 weeks]
  • Tune-401 Pharmacokinetics (Cmax) [Time frame: 8 weeks]
  • Tune-401 Pharmacokinetics (Tmax) [Time frame: 8 weeks]
  • Tune-401 Pharmacokinetics (AUC) [Time frame: 8 weeks]
  • Tune-401 Pharmacokinetics (CL) [Time frame: 8 weeks]
  • Tune-401 Pharmacokinetics (half-life) [Time frame: 8 weeks]
  • Tune-401 Pharmacokinetics (Vd) [Time frame: 8 weeks]
  • Tune-401 Pharmacodynamics [Time frame: 104 weeks]
  • Tune-401 Immunogenicity [Time frame: 104 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • Queen Mary Hospital, University of Hong Kong — Hong Kong
Moldova · 1 center
  • PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I — Chisinau
New Zealand · 1 center
  • New Zealand Clinical Research — Auckland

Identifiers

NCT: NCT06671093 · Tune-401-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗