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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
ABI-4334 Tablet
Placebo to ABI-4334 Tablet
New Zealand Clinical Research
Grafton, Auckland, New Zealand
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Time frame: Up to Day 14
SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334
Time frame: 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
Time frame: before and at pre-specified time points up to 144 hours after dosing
SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: before and at pre-specified time points up to 144 hours after dosing
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MAD Cohorts 1-2: AUC of ABI-4334
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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