AZD9773 Dose Escalation Study
Study identifier:D0620C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Placebo-controlled, double-blind, dose-escalation study to assess the safety, tolerability, and pharmacokinetics and pharmacodynamics of single and multiple intravenous infusions of CytoFab (AZD9773) in patients with severe sepsis
Medical condition
Severe Sepsis
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD9773 (CytoFab)
Sex
All
Actual Enrollment
70
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jan 2008
Primary Completion Date: 01 Jul 2009
Study Completion Date: 01 Jul 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD9773 cohort 1 (50 units/kg) AZD9773: single infusion of 50 units/kg | Drug: AZD9773 (CytoFab) intravenous infusions |
| Experimental: AZD9773 cohort 2 (250 units/kg) AZD9773: single infusion of 250 units/kg | Drug: AZD9773 (CytoFab) intravenous infusions |
| Experimental: AZD9773 cohort 3 (250/50 units/kg) AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs | Drug: AZD9773 (CytoFab) intravenous infusions |
| Experimental: AZD9773 cohort 4 (500/100 units/kg) AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs | Drug: AZD9773 (CytoFab) intravenous infusions |
| Experimental: AZD9773 cohort 5 (750/250 units/kg) AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs | Drug: AZD9773 (CytoFab) intravenous infusions |
| Placebo Comparator: Placebo Placebo | Other: Placebo Placebo |
Contacts
Investigators
Principal Investigator
Steven Simonson
AstraZeneca
