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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: 0.9% Normal Saline; Drug: CAZ-AVI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01920399

D4280C00020

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

IV infusions of 0.9% normal saline

Treatment:

Drug: 0.9% Normal Saline

CAZ-AVI

Experimental group

Description:

IV infusion of AVI 500 mg + CAZ 2000 mg.

Treatment:

Drug: CAZ-AVI