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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-20

Study Completion Date

2021-09-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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ATM-AVI treatment arm

Chinese healthy volunteers

Group Type EXPERIMENTAL

Aztreonam-Avibactam

Intervention Type DRUG

500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours

Interventions

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Aztreonam-Avibactam

500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes