RECRUITINGPhase 1INTERVENTIONAL
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
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
GENETIC
Tune-401
Epigenetic gene silencing therapy
Locations (3)
Queen Mary Hospital, University of Hong Kong
Hong Kong, Hong Kong
PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit
Chisinau, Moldova
New Zealand Clinical Research
Auckland, New Zealand