Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of ARO-MAPT-SC compared to placebo in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
112
• single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection
• calculated volume to match active treatment by SC administration
Research Site 1
Grafton, Auckland, New Zealand
RECRUITINGNumber of Participants with Treatment-Emergent Adverse Events (TEAEs) Over Time
Time frame: Through End of Study (EOS), Day 270
PK of ARO-MAPT-SC: Maximum Observed Plasma Concentration (Cmax)
Time frame: Through 48 hours postdose
PK of ARO-MAPT-SC: Time to Maximum Plasma Concentration (Tmax)
Time frame: Through 48 hours postdose
PK of ARO-MAPT-SC: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24)
Time frame: Through 24 hours postdose
PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to 48 Hours (AUC0-48)
Time frame: Through 48 hours postdose
PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUC0-t)
Time frame: Through 48 hours postdose
PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf)
Time frame: Through 48 hours post-dose
PK of ARO-MAPT-SC: Apparent Terminal Elimination Half-life (t1/2)
Time frame: Through 48 hours postdose
PK of ARO-MAPT-SC: Apparent Systemic Clearance (CL/F)
Time frame: Through 48 hours postdose
PK of ARO-MAPT-SC: Apparent Terminal-phase Volume of Distribution (Vz/F)
Time frame: Through 48 hours postdose
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PK of ARO-MAPT-SC: Amount Excreted (Ae) of Unchanged Drug in Urine From Time Zero to 24 Hours Postdose
Time frame: Through 24 hours postdose
PK of ARO-MAPT-SC: Percentage of Administered Drug Recovered (Fe) in Urine From Time Zero to 24 Hours Postdose
Time frame: Through 24 hours postdose
PK of ARO-MAPT-SC: Renal Clearance (CLR)
Time frame: Through 24 hours postdose
Change from Baseline in Total Protein in Cerebral Spinal Fluid (CSF) Over Time
Time frame: Baseline through EOS, Day 270
Change from Baseline in Glucose in CSF Over Time
Time frame: Baseline through EOS, Day 270
Change from Baseline in Cell Count in CSF Over Time
Time frame: Baseline through EOS, Day 270