Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
NCT ID: NCT06671093
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
36 participants
INTERVENTIONAL
2024-11-29
2028-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Tune-401 Part I : Single Ascending Dose
Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
Tune-401
Epigenetic gene silencing therapy
Tune-401 Part II :Single/Finite Multiple Dose
Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
Tune-401
Epigenetic gene silencing therapy
Interventions
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Tune-401
Epigenetic gene silencing therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Chronic Hepatitis B
* On nucleos(t)ide analogue
* HBeAg-negative or positive
Exclusion Criteria
* Participants with any evidence or history of liver disease of non-HBV etiology
18 Years
75 Years
ALL
No
Sponsors
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Tune Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Man Fung Yuen
Role: primary
Other Identifiers
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Tune-401-001
Identifier Type: -
Identifier Source: org_study_id
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