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First in Human Study for Safety and Tolerability of AL003.

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ClinicalTrials.gov Identifier: NCT03822208
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Alector Inc.

Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE March 29, 2019
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
Evaluation of safety and tolerability of AL003 measured by number of subjects with adverse events and dose limiting adverse events (DLAE) [ Time Frame: 134 days ]
Incidence of adverse events during the treatment and follow up periods through out the study.
Original Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
Evaluation of safety and tolerability of AL003 measured by number of subjects with adverse events and dose limiting adverse events (DLAE) [ Time Frame: 134 days ]
Incidence of adverse events and dose limiting adverse events during the DLAE observation period and/or study treatment periods.
Change History Complete list of historical versions of study NCT03822208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Pharmacokinetics (PK) of AL003 [ Time Frame: 85 days ]
    Serum and CSF concentration of AL003 at specific time points
  • Maximum concentration (Cmax) for AL003 [ Time Frame: 85 days ]
    Evaluate Cmax for serum and CSF concentration of AL003 at specified time points
  • Area under the curve concentration (AUC) for AL003 [ Time Frame: 85 days ]
    Evaluate AUC for serum and CSF concentration of AL003 at specified time points
Original Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • Pharmacokinetics (PK) of AL003 [ Time Frame: 85 days ]
    Serum and CSF concentration of AL003 at specific time points
  • Maximum plasma concentration (Cmax) for AL003 [ Time Frame: 85 days ]
    Evaluate Cmax for serum and CSF concentration of AL003 at specified time points
  • Area under the curve concentration (AUC) for AL003 [ Time Frame: 85 days ]
    Evaluate AUC for serum and CSF concentration of AL003 at specified time points
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First in Human Study for Safety and Tolerability of AL003.
Official Title  ICMJE 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.
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.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Healthy
  • Alzheimer Disease
Intervention  ICMJE
  • Biological: AL003
    Single-doses of AL003 in up to 7 dose-escalating cohorts
  • Other: 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
Study Arms  ICMJE
  • Active Comparator: AL003 by intravenous (IV) infusion
    single-doses of AL003 in dose-escalating cohorts
    Intervention: Biological: AL003
  • Placebo Comparator: Placebo by intravenous (IV) infusion
    Saline solution will be administered as a single infusion for each cohort for placebo subjects
    Intervention: Other: Saline Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Study Lead 415-231-5660 ext 329 info@alector.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03822208
Other Study ID Numbers  ICMJE AL003-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Alector Inc.
Study Sponsor  ICMJE Alector Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ben Snyder, MD Nucleus Network
PRS Account Alector Inc.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP