Study identifier:D0620C00005
ClinicalTrials.gov identifier:NCT01144624
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase II, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of Intravenous Infusions of AZD9773 (CytoFab™) in Japanese Patients with Severe Sepsis and/or Septic Shock
Severe Sepsis
Phase 2
No
AZD9773, Placebo
All
20
Interventional
20 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
-
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.
Location
Location
Kumamoto-Shi, Kumamoto, Japan
Location
Osaka, Osaka, Japan
Location
Sumiyoshi-ku, Osaka, Japan
Location
Hachioji, Tokyo, Japan
Location
Ohta-ku, Tokyo, Japan
Location
Kobe, Hyogo, Japan
Location
SAPPORO-SHI, Hokkaido, Japan
Arms | Assigned Interventions |
---|---|
Experimental: 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) | Drug: AZD9773 A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days Other Name: CytoFab™ |
Placebo Comparator: 2 | Drug: Placebo Intravenous infusion of a saline solution |
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