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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Research Site
Sapporo, Hokkaido, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kumamoto, Kumamoto, Japan
Research Site
Osaka, Osaka, Japan
Safety and Tolerability of AZD9773
Number of patients with treatment-emergent adverse events and number of patients who died over 28 days
Time frame: 28 day study period
Pharmacokinetics of AZD9773
Maximum concentration at steady state (Cmax ss) for serum total and specific fabs
Time frame: From first dose to last dose (Day 5/6 or at premature treatment discontinuation)
Pharmacodynamic Effects of AZD9773 on TNF-alpha
TNF-alpha levels over approximately 6 days following the first dose
Time frame: Levels taken at baseline, over the dosing period (up to Day 5/6)
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Research Site
Sumiyoshi-ku, Osaka, Japan
Research Site
Hachiōji, Tokyo, Japan
Research Site
Ohta-ku, Tokyo, Japan