ABSTRACT Combined treatment with aztreonam (an established intravenous antibiotic) and avibactam (a β‐lactamase inhibitor) has the potential to address the unmet need for safe and effective agents to combat infections caused by Gram‐negative bacteria producing metallo β‐lactamases (MBLs). Aztreonam–avibactam may also address other problematic β‐lactamases, such as extended‐spectrum β‐lactamases and serine carbapenemases, which may be co‐expressed with MBLs and contribute to a multidrug‐resistant phenotype. Based on completion of two Phase 3 trials, aztreonam–avibactam was approved in Europe (2024), the United States and China (2025). This Phase 1 open‐label study assessed the pharmacokinetics, safety, and tolerability of aztreonam–avibactam in healthy Chinese participants after single‐ and multiple‐dose administration (doses equivalent to those evaluated in Phase 3 aztreonam–avibactam trials), with a fixed 3:1 ratio. Pharmacokinetics, safety, and tolerability characteristics of aztreonam and avibactam were consistent with previous knowledge, with no clinically significant differences in exposures between Chinese and non‐Chinese participants. Based on population pharmacokinetic modeling which incorporated data from the aztreonam–avibactam Phase 1–3 trials, predicted aztreonam and avibactam exposures at steady state for Phase 3 participants in China and non‐China (rest‐of‐world) regions were numerically similar. These findings indicate that aztreonam–avibactam is well tolerated in healthy Chinese adults and support the use of the approved dose regimen by EMA for Chinese patient populations.
Wang et al. (Sun,) studied this question.