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Trial details imported from ClinicalTrials.gov
Ethics application status
First in Human Study for Safety and Tolerability of AL003.
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Doses of AL003 in Healthy Participants and in Participants With Mild to Moderate Alzheimer's Disease.
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Other interventions - AL003
Other interventions - Saline Solution
Active Comparator: AL003 by intravenous (IV) infusion - single-doses of AL003 in dose-escalating cohorts
Placebo Comparator: Placebo by intravenous (IV) infusion - Saline solution will be administered as a single infusion for each cohort for placebo subjects
Other interventions: AL003
Single-doses of AL003 in up to 7 dose-escalating cohorts
Other interventions: Saline Solution
Saline Solution will be administered as a single infusion for each cohort in a ration of 6 active and 2 placebo subjects for healthy adults and 10 active and 2 placebo for patients
Intervention code 
Comparator / control treatment
Primary outcome 
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.
Secondary outcome 
Pharmacokinetics (PK) of AL003 - Serum and CSF concentration of AL003 at specific time points
Secondary outcome 
Maximum concentration (Cmax) for AL003 - Evaluate Cmax for serum and CSF concentration of AL003 at specified time points
Secondary outcome 
Area under the curve concentration (AUC) for AL003 - Evaluate AUC for serum and CSF concentration of AL003 at specified time points
Key inclusion criteria
1. Total body weight between 50 and 120 kg, inclusive
2. Clinical laboratory evaluations (including chemistry panel fasted [at least 8 hours],
complete blood count (CBC), and urine analysis) within the reference range for the
test laboratory, unless deemed not clinically significant by the Investigator. A count
of the segmented neutrophils and bands should be performed when results from the white
blood cells (WBCs) are not within the reference range.
3. Negative test for selected drugs of abuse at screening (dose not include alcohol) and
at admission (does include alcohol breath test). A positive result may be verified by
re-testing (up to one false positive result permitted) and may be followed up at the
discretion of the Investigator.
4. Females must be non-pregnant and non-lactating, and either surgically sterile, using
double barrier method or abstinence.
5. In good health, determined by no clinically significant findings from medical history,
physical examination, 12-lead electrocardiogram (ECG), laboratory tests, and vital
For MD cohort
1. Ages 50-85 years, inclusive.
2. The participant should be capable of completing assessments either alone or with the
help of the study partner (where appropriate), per local guidelines.
3. Availability of a person ("study partner") who, in the Investigator's judgment, has
frequent and sufficient contact with the participant and is able to provide accurate
information regarding the participant's cognitive and functional abilities, agrees to
provide information at clinic visits, which require partner input for scale
completion, and signs the necessary consent form, per local guidelines.
4. Clinical diagnosis of probable Alzheimer's disease dementia based on National
Institute on Aging Alzheimer's Association criteria.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Pregnant or lactating, or intending to become pregnant within 16 weeks after last dose
of study drug.
2. Participation in a clinical trial within 30 days before randomization; use of any
experimental oral therapy within 30 days or 5 half-lives prior to Day 1, whichever is
greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to Day
1, whichever is greater. Participants who have received an experimental therapy that
has no half-life, like a vaccine, should have completed that therapy at least 12 weeks
prior to Day 1. Participants who have received an experimental vaccine against a
central nervous system (CNS) target, such as beta-amyloid or tau, are not eligible for
3. Any non-experimental vaccine within 2 weeks of randomization, until 2 weeks after the
last dose. It is advised that prospective participants receive their annual influenza
vaccine as early as possible in advance of the flu season, and then wait 2 weeks prior
to randomization. It is permitted to receive the annual influenza vaccine during the
4. Surgery or hospitalization during the 4 weeks prior to screening.
5. Planned procedure or surgery during the study.
6. Systemically, clinically significantly immunocompromised patients, owing to continuing
effects of immune suppressing medication.
7. Known history of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric, human, or humanized antibodies or fusion proteins.
8. Past history of seizures, with the exception of childhood febrile seizures.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Nucleus Network - Melbourne
Recruitment postcode(s) 
Primary sponsor type
Ethics application status
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.
Trial related presentations / publications