NCT01144624

A Study to Assess Safety,and Tolerability of 2 Doses of AZD9773 (CytoFab™) in Japanese With Severe Sepsis/Septic Shock

A Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous Infusions of AZD9773 (CytoFab™) in Japanese Patients With Severe Sepsis and/or Septic Shock

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The two co-primary objectives of this study are to assess in Japanese patients with severe sepsis and/or septic shock: 1) the safety and tolerability of two different doses of intravenous AZD9773 and 2) the PK of AZD9773. The secondary objective is to make a preliminary assessment of the pharmacodynamics of two different doses of intravenous AZD9773 in Japanese patients with severe sepsis and/or septic shock.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	AZD9773	A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
DRUG	Placebo	Intravenous infusion of a saline solution

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-06-15
• Last updated: 2014-10-06
• Results posted: 2013-08-22

Locations

7 sites across 1 country: Japan