AZD Single Ascending Dose Study In Healthy Japanese Subjects - JSAD

Study identifier:D0510C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Phase I, Single Centre, Open Label Study to Access The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after A) a Single Ascending Bolus Dose and B) a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Healthy Japanese Volunteers (age range 20-45 years)

Medical condition

Healthy

Phase

Phase 1

Healthy volunteers

Yes

Study drug

AZD3043

Sex

All

Actual Enrollment

72

Study type

Interventional

Age

20 Years - 45 Years

Date

Study Start Date: 01 Dec 2009
Primary Completion Date: 01 Aug 2010
Study Completion Date: 01 Aug 2010

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria