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

• Status: Completed
• Trial end date: 2021-09-27
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Pfizer
• Treatments: Avibactam; Aztreonam

Criteria

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