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
- Chisinau, MoldovaSee the site
- Phase
- Phase 1
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 Moldova
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I UnitChisinau, MoldovaTaking 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.