A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Ceftazidime-Avibactam Administered as Single and Repeated Intravenous Doses in Healthy Chinese Subjects

Investigate the safety and tolerability, as well as PK profile of ceftazidime-avibactam (CAZ -AVI) administered in single and repeated intravenous (IV) infusions in healthy Chinese subjects.This study data will be used to support CAZ-AVI NDA in China.

Key Inclusion Criteria:

• Provision of signed and dated, written informed consent prior to any study-specific procedures.
• Healthy male and female (of non-child bearing potential) Chinese subjects, with suitable veins for cannulation or repeated venipuncture
• BMI 19 to 24 kg/m2 inclusive and weigh at least 50 kg and no more than 100 kg.

Key Exclusion Criteria:

• Any clinical condition requiring the regular use of any medication.
• Consumption of alcohol, drug, tobacco (cigarettes).
• Sensitive to any food, or any serious reaction to carbapenem, cephalosporin, or other β-lactam antibiotics.
• Severe medical or psychiatric condition or laboratory abnormality.
• Blood donation.
• 12 lead ECG abnormal.