Study identifier:D4280C00010
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination with Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects
Healthy male and female Japanese volunteers
Phase 1
Yes
NXL104, CAZ104, Placebo
All
15
Interventional
20 Years - 45 Years
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verified 01 Jul 2015 by AstraZeneca Pharmaceuticals
AstraZeneca Pharmaceuticals
-
This is a single and multiple dose study in healthy male and female (of non-childbearing potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.
Location
Location
Glendale, CA, United States
Location
Baltimore, MD, United States
Arms | Assigned Interventions |
---|---|
Experimental: NXL104 Six Japanese subjects to receive single and repeated 500 mg IV infusions of NXL104 | Drug: NXL104 IV Solution |
Placebo Comparator: Placebo Three Japanese subjects to receive placebo IV doses | Drug: Placebo IV saline |
Experimental: Ceftazidime NXL104 (CAZ104) Six Japanese subjects to receive single and repeated IV infusions of 500 mg NXL104 with 2000 mg ceftazidime | Drug: CAZ104 IV Solution |
This information is not intended to replace the informed medical advice or medical treatments of a healthcare professional. Only a physician can determine if a specific medicine is the correct treatment for a particular patient. If you have questions regarding any information contained in this site, you must consult a suitably qualified healthcare professional. Before prescribing any AstraZeneca products, Healthcare Professionals should view their country specific information.