This is a first-in-human (FIH study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic effects of AKB-9090 in healthy adult participants. The study consists of two stages: Stage 1, a single ascending dose (SAD) phase with four dose cohorts, and Stage 2, a multiple ascending dose (MAD) phase with one dose cohort. Approximately 32 participants in SAD and 12 in MAD are planned to be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
44
Investigator Site #1
Auckland, New Zealand
RECRUITINGNumber of participants who will report serious Treatment emergent adverse events (TEAEs) and TEAEs
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Physical Examinations
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Vital Signs
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram (ECG)
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Chemistry parameters
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Hematology Parameters
Time frame: from first dose to Day 7
Number of Participants with Clinically Significant Changes in Lipid Parameters
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Coagulation Parameters
Time frame: From First Dose to Day 7
Number of Participants with Clinically Significant Changes in Urinalysis Parameters
Time frame: From First Dose to Day 7
Stage 1 SAD Cohorts: Maximum observed plasma concentration (Cmax) of AKB-9090
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Time frame: At Day 1
Stage 1 SAD Cohorts: Time of maximum plasma concentration (Tmax) of AKB-9090
Time frame: At Day 1
Stage 1 SAD Cohorts: Area under concentration time curve (AUC) from time 0 to the last observation (AUClast) of AKB-9090
Time frame: At Day 1
Stage 1 SAD Cohorts: Apparent body clearance (CL) of AKB-9090
Time frame: At Day 1
Stage 1 SAD Cohorts: AUC from time 0 to infinity (AUCinf) of AKB-9090
Time frame: At Day 1
Stage 1 SAD Cohorts: Terminal half-life (T1/2) of AKB-9090
Time frame: At Day 1
Stage 2 MAD Cohorts: Cmax of AKB-9090
Time frame: At Day 1 and Day 7
Stage 2 MAD Cohorts: Tmax of AKB-9090
Time frame: At Day 1 and Day 7
Stage 2 MAD Cohorts: AUC to 24 hours post-dose (AUC24) of AKB-9090
Time frame: At Day 1
Stage 2 MAD Cohorts: CL of AKB-9090
Time frame: At Day 1 and Day 7
Stage 2 MAD Cohorts: T1/2 of AKB-9090
Time frame: At Day 1 and Day 7
Stage 2 MAD Cohorts: AUC at Steady state (AUCss) of AKB-9090
Time frame: At Day 7
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Erythropoietin (EPO)
Time frame: Baseline (Day 1) and at 6, 12, 18, and 24 hours post-dose
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Red Blood Cell Count (RBC)
Time frame: Baseline (Day 1) and At Days 2, 8, and 13
Stage 1 SAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count
Time frame: Baseline (Day 1) and At Days 2, 8, and 13
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - EPO
Time frame: Baseline (Day 1 and Day 7) and at 6, 12, 18, and 24 hours post-dose
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - RBC
Time frame: Baseline (Day 1) and At Days 4, 8, 14, and 21
Stage 2 MAD Cohorts: Change from Baseline in Pharmacodynamic Biomarker - Reticulocyte Count
Time frame: Baseline (Day 1) and At Days 4, 8, 14, and 21