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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Epigenetic gene silencing therapy
Queen Mary Hospital, University of Hong Kong
Hong Kong, Hong Kong
RECRUITINGPMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit
Chisinau, Moldova
RECRUITINGNew Zealand Clinical Research
Auckland, New Zealand
RECRUITINGSafety as assessed by treatment emergent adverse events
Number of participants with treatment-related adverse events (TEAEs)
Time frame: 20 weeks
Long-term safety
Number of participants with TEAEs ( safety laboratory tests (hematology, biochemistry, coagulation parameters, and urinalysis) and vital signs of clinical significance)
Time frame: 104 weeks
Tune-401 Pharmacokinetics (Cmax)
Maximum concentration (Cmax)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (Tmax)
Time it takes to reach Cmax (Tmax)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (AUC)
Extrapolated area under the concentration-time curve (AUC-infinity)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (CL)
Clearance (CL)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (half-life)
Terminal half-life (t½)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (Vd)
Volume of distribution (Vd)
Time frame: 8 weeks
Tune-401 Pharmacodynamics
Changes from baseline in HBsAg
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 104 weeks
Tune-401 Immunogenicity
Development of anti-Tune-401 antibodies
Time frame: 104 weeks