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This study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple-ascending doses (MAD) of ABI-6250 in healthy participants. 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-6250 | Experimental | ||
| Part A: SAD Cohorts 1-5, Placebo | Placebo Comparator | ||
| Part A: SAD Food Effect Cohort 6 or 7: ABI-6250 | Experimental |
| |
| Part A: SAD Food Effect Cohort 6 (if applicable): Placebo | Placebo Comparator | ||
| Part B: MAD Cohorts 1-4, ABI-6250 | Experimental | ||
| Part B: MAD Cohorts 1-4, Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABI-6250 | Drug | Single dose (SAD) or once or twice daily dosing over 10 days (MAD) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results | From enrollment to 10 days after the last dose, at pre-specified timepoints | |
| Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints | |
| Maximum Observed Plasma Concentration (Cmax) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints | |
| Time to Cmax (Tmax) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints | |
| Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints | |
| Apparent Systemic Clearance (CL/F) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints | |
| Apparent Volume of Distribution (Vz/F) of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints | |
| Dose normalized AUCs and Cmax of ABI-6250 | From enrollment to 10 days after the last dose, at pre-specified timepoints |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of plasma AUC between fasted and fed treatments | From enrollment to 10 days after the last dose, at pre-specified timepoints | |
| Comparison of AUC between fasted and fed treatments | From enrollment to 10 days after the last dose, at pre-specified timepoints |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research | Auckland | New Zealand |
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| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| ID | Term |
|---|---|
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
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| Placebo | Drug | Single dose (SAD) or once or twice daily dosing over 10 days (MAD) |
|
| D006505 |
| Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |