A Study to assess safety,and tolerability of 2 doses of AZD9773 (CytoFab™) in Japanese with severe sepsis/septic shock

Exclusion Criteria

• - Immunocompromising comorbidities or concomitant medications:
• 1. Advanced human immunodeficiency virus (HIV) infection (CD4 ≤50/mm3).
• 2. Haemopoietic or lymphoreticular malignancies not in remission.
• 3. Receiving radiation therapy or chemotherapy.
• 4. Any organ or bone marrow transplant within the past 24 weeks.
• 5. Absolute neutrophil count <500 per μL.
• 6. High dose steroids or other immunocompromising drugs.
• - Concomitant diseases:
• 1. Deep-seated fungal infection or active tuberculosis.
• 2. Severe chronic liver disease associated with portal hypertension, cirrhosis, chronic ascites or Child-Pugh class C.
• 3. History of chronic hypercarbia, respiratory failure in past 6 months or use of home oxygen in the setting of severe chronic respiratory disease.
• 4. Neuromuscular disorders that impact breathing/spontaneous ventilation.
• 5. Quadriplegia.
• 6. Cardiac arrest in the past 30 days.
• 7. New York Heart Association functional Class III or IV due to heart failure or any disorder.
• 8. Burns over > 30% of body surface area in the past 5 days.
• - Medication and allergy disqualifications.
• 1. Treatment with anti-TNF agents within the last 8 weeks.
• 2. Previously received ovine derived products (CroFab™, DigiFab™).
• 3. Sheep product allergy or allergy to papain, chymopapain.