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
1 other identifier
interventional
36
3 countries
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2024
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2024
CompletedFirst Posted
Study publicly available on registry
November 4, 2024
CompletedStudy Start
First participant enrolled
November 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2028
January 6, 2026
January 1, 2026
3.6 years
October 28, 2024
January 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety as assessed by treatment emergent adverse events
Number of participants with treatment-related adverse events (TEAEs)
20 weeks
Secondary Outcomes (9)
Long-term safety
104 weeks
Tune-401 Pharmacokinetics (Cmax)
8 weeks
Tune-401 Pharmacokinetics (Tmax)
8 weeks
Tune-401 Pharmacokinetics (AUC)
8 weeks
Tune-401 Pharmacokinetics (CL)
8 weeks
- +4 more secondary outcomes
Study Arms (2)
Tune-401 Part I : Single Ascending Dose
EXPERIMENTALEpigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
Tune-401 Part II :Single/Finite Multiple Dose
EXPERIMENTALEpigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
Interventions
Epigenetic gene silencing therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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, MD2025, Moldova
New Zealand Clinical Research
Auckland, 1010, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2024
First Posted
November 4, 2024
Study Start
November 29, 2024
Primary Completion (Estimated)
June 28, 2028
Study Completion (Estimated)
October 30, 2028
Last Updated
January 6, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share