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

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

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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