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New hope for hepatitis b? early trial of Tune-401 begins
NCT ID NCT06671093
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests the safety of a new drug, Tune-401, in 36 adults with chronic hepatitis B. Participants must already be on standard antiviral medication. The goal is to see if Tune-401 is safe and how the body processes it, not yet to cure the infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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New Zealand Clinical Research
RECRUITINGAuckland, 1010, New Zealand
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PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit
RECRUITINGChisinau, MD2025, Moldova
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Queen Mary Hospital, University of Hong Kong
RECRUITINGHong Kong, Hong Kong
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a newer hepatitis b drug protect babies while being gentler on their bones?
- CRISPR 'Brake Release' may reawaken immune cells to beat hepatitis b
- Can a vaccine teach the immune system to fight hepatitis b?