AZD9773 Dose Escalation Study
AZD9773 Dose Escalation Study
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.
Inclusion Criteria:

 -  Clinical evidence of infection requiring treatment with parenteral antibiotics

 -  Patients must meet multiple Systemic Inflammatory Response Syndrome (SIRS) criteria

 -  Patients must meet criteria for cardiovascular and/or respiratory dysfunction

 -  Sepsis (infection plus SIRS criteria) must be present prior to organ dysfunction

 Exclusion Criteria:

 -  Moribund and death is considered imminent, or patient not expected to survive 90 days
 because of underlying medical condition, or classified as Do Not Resuscitate or Do Not
 Treat

 -  Patient cannot attain a MAP >60 mmHg when measured via an arterial line and/or a
 Systolic Blood Pressure (SBP) >80 mmHg in the presence of vasopressors and iv fluids
 for a period of ≥2 hours

 -  Receiving immunosuppressants, or high dose steroids within 2 months of provision of
 informed consent

 -  Any history of hypersensitivity reaction to sheep products, latex, papain or papaya,
 or chymopapain or previously administered antivenom manufactured using ovine serum,
 digoxin immune fab (DigiFab™ , DIGIBIND® ), crotalidae polyvalent immune fab (ovine)
 (CroFab™ ), or other sheep derived product.

 -  Treatment with anti Tumor-Necrosis-Factor (anti-TNF) antibodies within 8 weeks before
 provision of written informed consent.