Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Aztreonam-Avibactam

Study type: Interventional

Funder types: Industry

Identifiers

NCT04973826

C3601007

Details and patient eligibility

About

A Phase 1, single center, single arm, open-label study to assess the PK, safety and tolerability of Aztreonam-Avibactam after single and repeated IV infusion of doses in healthy Chinese participants.

Enrollment: 12 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Chinese male and female participants
• No clinical relevant abnormalities
• willing and able to comply with all study procedures
• BMI:17.5-30.5
• Sign informed consent

Exclusion criteria

• Any clinical significant illness
• History of alcohol abuse
• Use within 14 days prior the first study dose
• CL>80ml/min
• Abnormal vital signs, such 12-ECG, blood pressure and pulse rate
• Blood donation within 60days
• History of HIV, HBsAg, HBcAb, HCVAb
• Other medical or psychiatric may inappropriate for the study

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

ATM-AVI treatment arm

Experimental group

Description:

Chinese healthy volunteers

Treatment:

Drug: Aztreonam-Avibactam