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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca; Pfizer
• Treatments: Avibactam; Avibactam, ceftazidime drug combination; Ceftazidime

Criteria

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.