Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Recruiting · NCT06671093 · Interventional (participants receive a specific treatment) · Lead sponsor: Tune Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
Tune-401
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed.
- New Zealand Clinical Research - Auckland, New Zealand
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit - Chisinau, Moldova
- Queen Mary Hospital, University of Hong Kong - Hong Kong, Hong Kong