Tests Tune-401 safety in adults with chronic hepatitis B
Tests the new Tune-401 treatment for safety in adults with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Key facts
- Where
- Auckland, New ZealandSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic hepatitis B who are already taking a nucleos(t)ide analogue medicine.
- Age
- 18 to 75 years
- Sex
- Men and women can join.
- Disease stage
- Chronic hepatitis B infection. HBeAg can be negative or positive.
- Earlier treatment
- People must be taking a nucleos(t)ide analogue.
- Biomarker or test result
- HBeAg-negative or HBeAg-positive. Body mass index (BMI) of 18.5 kg/m² or more at screening.
Main reasons for not taking part
- ALT/AST of 1.5 × the upper limit of normal (ULN) or more together with total bilirubin of 1.5 × ULN or more
- Any sign or history of liver disease not caused by hepatitis B virus
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06671093, who can take part
Where in New Zealand
- New Zealand Clinical ResearchAuckland, New ZealandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tune Therapeutics, Inc.
- Trial code
- NCT06671093
- Record updated
- 6 January 2026
- Original description
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.Read full original descriptionShow less
Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection
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.
Inclusion: 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: Participants with any evidence or history of liver disease of non-HBV etiology; ALT/ AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN; Other protocol defined Inclusion/Exclusion criteria may apply.