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MEDI1814 for

Phase 1

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

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

Clinical trial landscape

MEDI1814 for · 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 for

What is MEDI1814 used for?

MEDI1814 is an investigational monoclonal antibody being studied for the treatment of mild to moderate Alzheimer's disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated for its safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with this condition.

Who is developing MEDI1814?

MEDI1814 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research to evaluate the drug's potential in treating mild to moderate Alzheimer's disease.

What phase is MEDI1814 in?

MEDI1814 is in Phase 1 clinical development. A Phase 1 study has been completed, which assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in subjects with mild to moderate Alzheimer's disease. The drug remains investigational and is not yet approved for clinical use.

What clinical trials is MEDI1814 in?

MEDI1814 has one completed clinical trial registered under NCT02036645. This Phase 1 study was a single ascending dose and multiple ascending dose trial that evaluated the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in subjects with mild to moderate Alzheimer's disease and healthy elderly individuals.

Was the MEDI1814 clinical trial randomized and controlled?

Yes, the completed Phase 1 trial for MEDI1814 was a randomized, double-blind, placebo-controlled study. The trial enrolled 77 participants in the United States, with a minimum age of 55 years. The study included both male and female subjects and did not enroll healthy volunteers.