SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
NCT ID: NCT02036645
Last Updated: 2019-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
77 participants
INTERVENTIONAL
2014-02-04
2016-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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IV Placebo
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
MEDI1814 for IV injection
Monoclonal antibody for IV Injection
IV Placebo
Placebo for IV injection
MEDI1814 Sub Cutaneous Injection
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
MEDI1814 for Subcutaneous Injection
Monoclonal antibody for subcutaneous injection
MEDI1814 IV
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
MEDI1814 for IV injection
Monoclonal antibody for IV Injection
Subcutaneous Placebo
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Placebo for Subcutaneous Injection
Subcutaneous Placebo Injection
Interventions
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MEDI1814 for IV injection
Monoclonal antibody for IV Injection
MEDI1814 for Subcutaneous Injection
Monoclonal antibody for subcutaneous injection
IV Placebo
Placebo for IV injection
Placebo for Subcutaneous Injection
Subcutaneous Placebo Injection
Eligibility Criteria
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Inclusion Criteria
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
55 Years
85 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Thor Ostenfeld, MD
Role: STUDY_DIRECTOR
AstraZeneca
David Han, MD
Role: PRINCIPAL_INVESTIGATOR
Glendale Parexel Early Phase Clinical Unit
Locations
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Research Site
Glendale, California, United States
Research Site
Long Beach, California, United States
Research Site
Panorama City, California, United States
Research Site
Hallandale, Florida, United States
Research Site
Hialeah, Florida, United States
Research Site
Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Baltimore, Maryland, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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D4750C00001
Identifier Type: -
Identifier Source: org_study_id
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