This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
ABI-H3733 liquid oral dosage form
ABI-H3733 solid oral dosage form
Placebo to ABI-H3733 liquid oral dosage form
Placebo to ABI-H3733 solid oral dosage form
Auckland Clinical Studies
Auckland, New Zealand
Number of Participants with One or More Adverse Events
Time frame: Up to Day 10
Number of Participants with One or More Related Adverse Events
Time frame: Up to Day 10
Number of Participants with One or More Severe (Grade ≥3) Adverse Events
Time frame: Up to Day 10
SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Apparent Terminal Elimination Half-life (t1/2) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
MAD Cohorts 8-10: AUC of ABI-H3733
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
MAD Cohorts 8-10: Cmax Over the Dosing Interval of ABI-H3733
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
MAD Cohorts 8-10: Tmax of ABI-H3733
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
MAD Cohorts 8-10: t1/2 of ABI-H3733
Time frame: before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
Single Dose Cohorts 11-12: AUC of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
Single Dose Cohorts 11-12: Cmax of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
Single Dose Cohorts 11-12: Tmax of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
Single Dose Cohorts 11-12: t1/2 of ABI-H3733
Time frame: before and at pre-specified time points up to 120 hours after dosing
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