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

NCT01144624 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-10-06

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Justin Lindemann, MD · AstraZeneca

  • Wayne Dankner, MD · PAREXEL International Medical Services

  • Warren Botnick, MD · PAREXEL International Medical Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Japan

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01144624 on ClinicalTrials.gov