This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation first in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's disease. The study is designed to systematically assess the safety (including immunogenicity) and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL003.
The study will be conducted in 2 phases: In the single ascending dose (SAD) phase, up to approximately 42 healthy adult participants will be sequentially enrolled into up to approximately 7 cohorts. In the multiple-dose (MD) phase, approximately 12 patients with mild to moderate Alzheimer's disease will be enrolled in one cohort.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in a single cohort
Saline Solution will be administered as a single infusion for each dose escalation cohort in a ratio of 6 active and 2 placebo and as multiple infusions in the single cohort in a ratio of 10 active and 2 placebo
Brain Matters Research
Delray Beach, Florida, United States
Charter Research
Lady Lake, Florida, United States
PPD Clinical Research Unit
Orlando, Florida, United States
Synexus AES
The Villages, Florida, United States
Evaluation of safety and tolerability of AL003 measured by number of subjects with adverse events and dose limiting adverse events (DLAE)
Incidence of adverse events during the treatment and follow up periods through out the study.
Time frame: 141 days
Pharmacokinetics (PK) of AL003
Serum and CSF concentration of AL003 at specific time points
Time frame: 85 days
Maximum concentration (Cmax) for AL003
Evaluate Cmax for serum and CSF concentration of AL003 at specified time points
Time frame: 85 days
Area under the curve concentration (AUC) for AL003
Evaluate AUC for serum and CSF concentration of AL003 at specified time points
Time frame: 85 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Columbia University
New York, New York, United States
Nucleus Network
Melbourne, Australia