This is a study to evaluate the safety, tolerability and pharmacokinetics (PK) of AZD9742 after single IV doses in healthy subjects
Study identifier:D2690C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase-1, Single Center, Double Blind, Randomized, Placebo-controlled, Parallel-group Study to assess the Safety, Tolerability and Pharmacokinetics of Intravenous AZD9742 after Single Ascending Doses in Healthy Male and Female Subjects
Medical condition
Healthy
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AZD9742, Placebo to match AZD9742
Sex
All
Actual Enrollment
48
Study type
Interventional
Age
23 Years - 45 Years
Date
Study Start Date: 01 Nov 2009
Primary Completion Date: 01 Mar 2010
Study Completion Date: 01 Mar 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Quintiles, Inc.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD9742 IV Infusion Active | Drug: AZD9742 Increasing single IV infusion doses of AZD9742 given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo). Specific doses will be selected by the safety review committee |
| Placebo Comparator: Placebo to AZD9742 IV Infusion Placebo | Drug: Placebo to match AZD9742 Single IV infusion of AZD9742 placebo given to approximately 6 cohorts of 8 subjects each (6 on active and 2 on placebo) |
Contacts
Investigators
Principal Investigator
Dr. Ralph A Schutz
Quintiles, Inc
