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MEDI1814

Phase 1

Mild-Moderate Alzheimer's Disease | Monoclonal antibody | Neurology |AstraZeneca PLC|Trials Updated: Jun 3, 2019

MEDI1814 target and mechanism

ModalityMonoclonal antibody

Also known as MEDI1814 for IV injection

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

MEDI1814 clinical trials

MEDI1814 · 1 trial · 2 indications

Phase 1 1
NCT02036645SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.Mild-Moderate Alzheimer's Disease
COMPLETED77 Analytics
PHASE1COMPLETED
SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.
Mild-Moderate Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Tolerability as Measured by Participant Withdrawal for an Adverse Event
4 months SAD; 7 months MAD

Tolerability measured by participant withdrawal for an adverse event from randomization through end of study

Secondary Endpoints

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)
1 month
Maximum Plasma Concentration (Cmax) of Medi1814
1 month
Mean Termination Half Life (t 1/2) of Medi1814
1 month
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
MEDI1814 IVEXPERIMENTALUpto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
IV PlaceboPLACEBO_COMPARATORUpto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
MEDI1814 Sub Cutaneous InjectionEXPERIMENTAL2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Subcutaneous PlaceboPLACEBO_COMPARATOR2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort

Interventions

NameTypeDescription
MEDI1814 for IV injectionBIOLOGICALMonoclonal antibody for IV Injection
MEDI1814 for Subcutaneous InjectionBIOLOGICALMonoclonal antibody for subcutaneous injection
IV PlaceboBIOLOGICALPlacebo for IV injection
Placebo for Subcutaneous InjectionBIOLOGICALSubcutaneous Placebo Injection
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Eligibility Criteria

Age Range55 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites10

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 imp...

Countries:United States
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Frequently asked questions about MEDI1814

What is MEDI1814 for?

MEDI1814 is an investigational monoclonal antibody being studied for the treatment of mild to moderate Alzheimer's disease. It was evaluated in a Phase 1 clinical trial that enrolled 77 participants, including patients with mild to moderate Alzheimer's disease and healthy elderly volunteers. The study has been completed.

Who is developing MEDI1814?

MEDI1814 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the Phase 1 study of MEDI1814 in mild to moderate Alzheimer's disease.

What phase is MEDI1814 in?

MEDI1814 is in Phase 1 clinical development. The single Phase 1 trial, NCT02036645, has been completed. MEDI1814 is investigational and has not been approved by the FDA for any indication.

What clinical trials is MEDI1814 in?

MEDI1814 was studied in one Phase 1 clinical trial, NCT02036645, titled a single ascending dose and multiple ascending dose study to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of MEDI1814 in subjects with mild to moderate Alzheimer's disease. The trial enrolled 77 participants in the United States and is completed.

Is MEDI1814 the same as MEDI1814 for IV injection?

Yes. MEDI1814 for IV injection is an alternative name for MEDI1814, the investigational monoclonal antibody developed by AstraZeneca for mild to moderate Alzheimer's disease. Both names refer to the same drug candidate.

What type of drug is MEDI1814?

MEDI1814 is a monoclonal antibody. It is being developed as an investigational therapy for mild to moderate Alzheimer's disease and was tested in a Phase 1 trial that included both patients with Alzheimer's disease and healthy elderly volunteers.