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SAD/MAD Study to Assess Safety, Tolerability, PK & PD of MEDI1814 in Subjects With Mild-Moderate Alzheimer's Disease.

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 1

Conditions

Healthy Elderly
Mild-Moderate Alzheimer's Disease

Treatments

Biological: Placebo for Subcutaneous Injection
Biological: MEDI1814 for IV injection
Biological: MEDI1814 for Subcutaneous Injection
Biological: IV Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02036645
D4750C00001

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

77 participants in 4 patient groups, including a placebo group

MEDI1814 IV
Experimental group
Description:
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Treatment:
Biological: MEDI1814 for IV injection
IV Placebo
Placebo Comparator group
Description:
Upto 10 cohorts of subjects are planned to be dosed by IV injection, with single and multiple ascending doses ranging from 25-1800mg.
Treatment:
Biological: MEDI1814 for IV injection
Biological: IV Placebo
MEDI1814 Sub Cutaneous Injection
Experimental group
Description:
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Treatment:
Biological: MEDI1814 for Subcutaneous Injection
Subcutaneous Placebo
Placebo Comparator group
Description:
2 cohorts of subjects are planned to be dosed by sub cutaneous injection, one single ascending dose and one multiple ascending dose cohort
Treatment:
Biological: Placebo for Subcutaneous Injection

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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