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Taking people in MoldovaPhase 1

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

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 Moldova

  • PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I UnitChisinau, MoldovaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

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.

ClinicalTrials.gov NCT06671093