Conditions: Severe Sepsis Septic Shock
Keywords: TNF neutralisation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 20
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: AZD9773 250 units/kg (1 infusion) + 50 units/kg (9 infusions) (Dose Cohort 1):

AZD9773 500 units/kg (1 infusion) + 100 units/kg (9 infusions) (Dose Cohort 2) arm 2: None

Interventions: intervention 1: AZD9773 intervention 2: Placebo
Intervention descriptions: intervention 1: A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days intervention 2: Intravenous infusion of a saline solution

Protocol document: