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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03822208




Registration number
NCT03822208
Ethics application status
Date submitted
28/01/2019
Date registered
30/01/2019
Date last updated
17/09/2021

Titles & IDs
Public title
First in Human Study for Safety and Tolerability of AL003.
Scientific title
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.
Secondary ID [1] 0 0
AL003-1
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Alzheimer Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
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 Multiple doses of AL003 in single cohort

Placebo Comparator: Placebo by intravenous (IV) infusion - Matching saline solution will be administered for placebo subjects


Other interventions: AL003
Single-doses of AL003 in dose-escalating cohorts
Multiple doses of AL003 in a single cohort

Other interventions: Saline Solution
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Evaluation of safety and tolerability of AL003 measured by number of subjects with adverse events and dose limiting adverse events (DLAE)
Timepoint [1] 0 0
141 days
Secondary outcome [1] 0 0
Pharmacokinetics (PK) of AL003
Timepoint [1] 0 0
85 days
Secondary outcome [2] 0 0
Maximum concentration (Cmax) for AL003
Timepoint [2] 0 0
85 days
Secondary outcome [3] 0 0
Area under the curve concentration (AUC) for AL003
Timepoint [3] 0 0
85 days

Eligibility
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
signs.

For MD cohort

1. Ages 50-85 years, inclusive.

2. The participant should be capable of completing assessments alone, 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.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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
this study.

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
screening period.

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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/05/2021
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
New York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Alector Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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 website
https://clinicaltrials.gov/ct2/show/NCT03822208
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Paul, MD
Address 0 0
Alector Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries