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This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: SAD Cohorts 1-5 ABI-4334 Tablet | Experimental | A single dose of ABI-4334 will be administered on Day 1 in dose-escalation cohorts with a starting dose of 30 mg. The doses for subsequent cohorts will be determined by evaluation of safety and PK data from previous cohorts. |
|
| Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet | Placebo Comparator | A single dose of placebo matching ABI-4334 will be administered on Day 1. |
|
| Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet | Experimental | A single dose of ABI-4334 will be administered after a high-fat meal on Day 1 in cohort 6. A single dose of ABI-4334 will be administered on two separate occasions, once fasted and once after a high-fat meal in cohort 7. The dose administered will be determined after evaluation of cumulative safety and PK data from cohorts 1-5. |
|
| Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet | Placebo Comparator | A single dose of placebo matching ABI-4334 will be administered on Day 1 after a high-fat meal on Day 1 in cohort 6. |
|
| Part B: MAD Cohorts 1-2 ABI-4334 Tablet | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-4334 Tablet | Drug | ABI-4334 Tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results | Up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing | |
| SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Gane | New Zealand Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Grafton | Auckland | 1010 | New Zealand |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2022 | Jun 21, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Once-daily doses of ABI-4334 will be administered from Day 1 to Day 8. Cohort B1 will receive a dose determined from evaluation of the data from the SAD cohorts. The doses for the subsequent cohort will be determined by evaluation of safety and PK data from previous cohorts.
|
| Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet | Placebo Comparator | Once-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8. |
|
| ABI-4334 Placebo | Drug | Placebo to ABI-4334 Tablet |
|
| SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334 | before and at pre-specified time points up to 144 hours after dosing |
| MAD Cohorts 1-2: AUC of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: Cmax of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: Tmax of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: t 1/2 of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: CL/F of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| MAD Cohorts 1-2: Vz/F of ABI-4334 | before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8 |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |