Chronic Hepatitis, Chronic Hepatitis b, Chronic Hep B, HBV
Conditions
Keywords
Tune-401, Tune-401-001, CHB
Brief summary
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.
Detailed 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.
Interventions
GENETICTune-401
Epigenetic gene silencing therapy
Sponsors
Tune Therapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by treatment emergent adverse events | 20 weeks | Number of participants with treatment-related adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tune-401 Pharmacokinetics (Cmax) | 8 weeks | Maximum concentration (Cmax) |
| Tune-401 Pharmacokinetics (Tmax) | 8 weeks | Time it takes to reach Cmax (Tmax) |
| Tune-401 Pharmacokinetics (AUC) | 8 weeks | Extrapolated area under the concentration-time curve (AUC-infinity) |
| Tune-401 Pharmacokinetics (CL) | 8 weeks | Clearance (CL) |
| Long-term safety | 104 weeks | Number of participants with TEAEs ( safety laboratory tests (hematology, biochemistry, coagulation parameters, and urinalysis) and vital signs of clinical significance) |
| Tune-401 Pharmacokinetics (Vd) | 8 weeks | Volume of distribution (Vd) |
| Tune-401 Pharmacodynamics | 104 weeks | Changes from baseline in HBsAg |
| Tune-401 Immunogenicity | 104 weeks | Development of anti-Tune-401 antibodies |
| Tune-401 Pharmacokinetics (half-life) | 8 weeks | Terminal half-life (t½) |
Countries
Hong Kong, Moldova, New Zealand
Contacts
Primary ContactTune Therapeutics, Inc.
Outcome results
None listed