Conditions: Severe Sepsis
Keywords: Sepsis septic shock Systemic Inflammatory Response Syndrome
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 70
Healthy volunteers: no

Brief summary:
This is a double-blind, placebo-controlled, multi-center, dose-escalation study to assess the safety, tolerability, Pharmacokinetics and Pharmacodynamics of single and multiple ascending intravenous infusions of CytoFab (AZD9773) in adult patients with severe sepsis.

Detailed description:

Arms:
arm 1: AZD9773: single infusion of 50 units/kg arm 2: AZD9773: single infusion of 250 units/kg arm 3: AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs arm 4: AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs arm 5: AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs arm 6: Placebo

Interventions: intervention 1: AZD9773 (CytoFab) intervention 2: Placebo
Intervention descriptions: intervention 1: intravenous infusions intervention 2: Placebo

Protocol document: