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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tune-401 Part I : Single Ascending Dose | Experimental | Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration |
|
| Tune-401 Part II :Single/Finite Multiple Dose | Experimental | Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tune-401 | Genetic | Epigenetic gene silencing therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by treatment emergent adverse events | Number of participants with treatment-related adverse events (TEAEs) | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term safety | Number of participants with TEAEs ( safety laboratory tests (hematology, biochemistry, coagulation parameters, and urinalysis) and vital signs of clinical significance) | 104 weeks |
| Tune-401 Pharmacokinetics (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tune Therapeutics, Inc. | Contact | 855 755 8863 | clinical.operations@tunetx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital, University of Hong Kong | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006521 | Hepatitis, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Maximum concentration (Cmax)
| 8 weeks |
| Tune-401 Pharmacokinetics (Tmax) | Time it takes to reach Cmax (Tmax) | 8 weeks |
| Tune-401 Pharmacokinetics (AUC) | Extrapolated area under the concentration-time curve (AUC-infinity) | 8 weeks |
| Tune-401 Pharmacokinetics (CL) | Clearance (CL) | 8 weeks |
| Tune-401 Pharmacokinetics (half-life) | Terminal half-life (t½) | 8 weeks |
| Tune-401 Pharmacokinetics (Vd) | Volume of distribution (Vd) | 8 weeks |
| Tune-401 Pharmacodynamics | Changes from baseline in HBsAg | 104 weeks |
| Tune-401 Immunogenicity | Development of anti-Tune-401 antibodies | 104 weeks |
| PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit | Recruiting | Chisinau | MD2025 | Moldova |
|
| New Zealand Clinical Research | Recruiting | Auckland | 1010 | New Zealand |
|
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |