NCT06671093RecruitingPhase 1
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 28 Oct 2024
- Start date
- 29 Nov 2024
- Primary completion date
- 28 Jun 2028
- Lead sponsor
- Tune Therapeutics, Inc.
- Diseases
- Hepatitis B
- NCT number
- NCT06671093
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 36
- From 29 Nov 2024 to the primary completion date, 28 Jun 2028
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Participants with any evidence or history of liver disease of non-HBV etiology
Lab values
- ALT/ AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN
Other
- Other protocol defined Inclusion/Exclusion criteria may apply
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Queen Mary Hospital University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Recruiting |
| PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit Coordinator of this site? Confirm its status | Chisinau | Moldova | Recruiting |
| New Zealand Clinical Research Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.