This is a multi-centre, 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 AL002.
The study will be conducted in 2 phases: In the single ascending dose (SAD) phase up to approximately 56 healthy adult participants will be sequentially enrolled into up to approximately 9 cohorts In the multiple-dose (MD) phase, approximately 32 patients with mild to moderate Alzheimer's disease will be enrolled in three cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
69
Single-doses of AL002 in up to 9 dose-escalating cohorts
Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects for HV and 10 active and 2 placebo for patients
Brain Matters Research
Delray Beach, Florida, United States
Compass Research - Orlando
Orlando, Florida, United States
Compass Research - The Villages
The Villages, Florida, United States
Columbia University
New York, New York, United States
Evaluation of safety and tolerability of AL002 measured by number of subjects with adverse events and Dose Limiting Adverse Event (DLAEs)
Incidence of adverse events and dose limiting Adverse Events during the DLAE observation period and/or study treatment periods.
Time frame: 141 days
Pharmacokinetics (PK) of AL002
Serum and CSF concentration of AL002 at specified time points
Time frame: 85 days
Maximum plasma concentration (Cmax) for AL002
Evaluate Cmax for serum and CSF concentration of AL002 at specified time points
Time frame: 85 days
Area under the curve concentration (AUC) for AL002
Evaluate AUC for serum and CSF concentration of AL002 at specified time points
Time frame: 85 days
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Nucleus Network Pty Ltd
Melbourne, Australia
University College London
London, United Kingdom