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

CompletedPhase 1

Sponsor: Pfizer

Conditions: Healthy

Interventions: Aztreonam-Avibactam

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Shanghai, Shanghai Municipality, China