Back to resultsSAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
Primary Purpose
Mild-Moderate Alzheimer's Disease, Healthy Elderly
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MEDI1814 for IV injection
MEDI1814 for Subcutaneous Injection
IV Placebo
Placebo for Subcutaneous Injection
Sponsored by
About this trial
This is an interventional basic science trial for Mild-Moderate Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria Male and female (non child bearing potential) subjects Mild-moderate Alzheimer's Disease
Exclusion Criteria History or evidence of significant autoimmune disease Presence of psychiatric disorder which would affect completion of the study Current serious or unstable clinically important illness
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
MEDI1814 IV
IV Placebo
MEDI1814 Sub Cutaneous Injection
Subcutaneous Placebo
Arm Description
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Outcomes
Primary Outcome Measures
Tolerability as Measured by Participant Withdrawal for an Adverse Event
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
Secondary Outcome Measures
Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)
Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)
Maximum Plasma Concentration (Cmax) of Medi1814
Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)
Mean Termination Half Life (t 1/2) of Medi1814
Mean termination half life (t 1/2) of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)
Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)
Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline
Biomarker: Total Amyloid-beta 1-42 in Plasma
Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline
Medi1814 Concentration in CSF Samples
Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification
Immunogenicity: Anti-drug Antibody Titer
Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all <50
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02036645
Brief Title
SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
Official Title
A Randomised, Double-Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MEDI1814 in Subjects With Mild to Moderate Alzheimer's Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 4, 2014 (Actual)
Primary Completion Date
September 15, 2016 (Actual)
Study Completion Date
September 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the safety, drug levels and effects on the body of 1 or 3 injections of MEDI1814, in people with mild to moderate Alzhiemer's Disease or healthy elderly people.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild-Moderate Alzheimer's Disease, Healthy Elderly
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MEDI1814 IV
Arm Type
Experimental
Arm Description
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Arm Title
IV Placebo
Arm Type
Placebo Comparator
Arm Description
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Arm Title
MEDI1814 Sub Cutaneous Injection
Arm Type
Experimental
Arm Description
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Arm Title
Subcutaneous Placebo
Arm Type
Placebo Comparator
Arm Description
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Intervention Type
Biological
Intervention Name(s)
MEDI1814 for IV injection
Intervention Description
Monoclonal antibody for IV Injection
Intervention Type
Biological
Intervention Name(s)
MEDI1814 for Subcutaneous Injection
Intervention Description
Monoclonal antibody for subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
IV Placebo
Intervention Description
Placebo for IV injection
Intervention Type
Biological
Intervention Name(s)
Placebo for Subcutaneous Injection
Intervention Description
Subcutaneous Placebo Injection
Primary Outcome Measure Information:
Title
Tolerability as Measured by Participant Withdrawal for an Adverse Event
Description
Tolerability measured by participant withdrawal for an adverse event from randomization through end of study
Time Frame
4 months SAD; 7 months MAD
Secondary Outcome Measure Information:
Title
Area Under the Concentration Time Curve (AUC) Time 0 to t (28 Days After 1st Dose SAD and MAD and After 3rd Dose in MAD, Day 57)
Description
Area Under the Concentration time curve (AUC) time 0 to t; calculated from Just prior to dose administration start to 28th day after dose (pre infusion, during infusion, 1,2,4,8,24,48 hr 7, 14, 21, and 28 day)
Time Frame
1 month
Title
Maximum Plasma Concentration (Cmax) of Medi1814
Description
Maximum plasma concentration (Cmax) of Medi1814 during 28 day period after dose administration start (prior to dosing, during infusion, 1, 2, 4, 8, 24, 48 hr, 7, 14,21, and 28 days)
Time Frame
1 month
Title
Mean Termination Half Life (t 1/2) of Medi1814
Description
Mean termination half life (t 1/2) of Medi1814 during 28 day period after dose administration start (SAD Day 1 dose, MAD 3rd dose)
Time Frame
1 month
Title
Biomarkers: Amyloid-beta in Cerebral Spinal Fluid (Two Amyloid Bets Peptides of 40 and 42 Amino Acids Were Assessed)
Description
Biomarkers: Amyloid-beta in cerebral spinal fluid, mean percent change from baseline
Time Frame
Day 29 in SAD; Day 85 in MAD
Title
Biomarker: Total Amyloid-beta 1-42 in Plasma
Description
Biomarker: Total Amyloid-beta 1-42 in plasma, mean percent change from baseline
Time Frame
Day 29 in SAD; Day 85 in MAD
Title
Medi1814 Concentration in CSF Samples
Description
Medi1814 concentration in CSF Samples; number of sampled subjects with a value above the lower limit of quantification
Time Frame
SAD Day 29; MAD Day 85
Title
Immunogenicity: Anti-drug Antibody Titer
Description
Immunogenicity: Anti-drug antibody titer, subject counted if titer 50 or greater on any test, else 0 if all <50
Time Frame
4 months SAD (6 tests over 4 months; week 1, 2, 4, 8, 12, 16); 7 months MAD (7 monthly tests)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Male and female (non child bearing potential) subjects Mild-moderate Alzheimer's Disease
Exclusion Criteria History or evidence of significant autoimmune disease Presence of psychiatric disorder which would affect completion of the study Current serious or unstable clinically important illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thor Ostenfeld, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David Han, MD
Organizational Affiliation
Glendale Parexel Early Phase Clinical Unit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Research Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Research Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
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