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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
New Zealand Clinical Research
Auckland, New Zealand
Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Maximum Observed Plasma Concentration (Cmax) of ABI-6250
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Time to Cmax (Tmax) of ABI-6250
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Systemic Clearance (CL/F) of ABI-6250
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Volume of Distribution (Vz/F) of ABI-6250
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Dose normalized AUCs and Cmax of ABI-6250
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Comparison of plasma AUC between fasted and fed treatments
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
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Comparison of AUC between fasted and fed treatments
Time frame: From enrollment to 10 days after the last dose, at pre-specified timepoints