Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Phase 1 – testing safety in a small group of people
Conditions:
Chronic Hep B
Chronic Hepatitis b
Chronic Hepatitis
HBV
Sponsor: Tune Therapeutics, Inc.
trial.available_in:
БГ
Overview
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.
Description
This study consists of an open-label, Part I single-ascending dose phase and Part II single and finite multiple dose phase to characterize the activity of Tune-401 on PD parameters and obtain safety data.
Who can participate
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
Locations
3
Hong Kong (1)
Queen Mary Hospital, University of Hong Kong
Hong Kong
Moldova (1)
PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit
БГ