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

Phase 1 Completed 12 enrolled Pfizer

NaSingle-groupOpen-labelOther

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.

Timeline

Start: 2021-08-20
Primary completion: 2021-09-27
Completion: 2021-09-27

Publications

Wang J, He J, Wu J, Zhang J, Ma Y, Ren X, Wei H, Zhang C, Zhu H, Raber SR, Cong S. Pharmacokinetics of Aztreonam-Avibactam After Single- and Multiple-Dose Administration: A Phase 1, Open-Label Study in Healthy Chinese Participants and Ethnic Comparison with Non-Chinese Participants. Clin Pharmacol Drug Dev. 2026 Feb;15(2):e70040. doi: 10.1002/cpdd.70040.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aztreonam	Small molecule	1500 mg	Intravenous
Subject	avibactam	Small molecule	500 mg	Intravenous

Indications

No indication recorded.