{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T10:43:23Z","timestamp":1779878603686,"version":"3.53.1"},"reference-count":26,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T00:00:00Z","timestamp":1771459200000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Combined treatment with aztreonam (an established intravenous antibiotic) and avibactam (a \u03b2\u2010lactamase inhibitor) has the potential to address the unmet need for safe and effective agents to combat infections caused by Gram\u2010negative bacteria producing metallo \u03b2\u2010lactamases (MBLs). Aztreonam\u2013avibactam may also address other problematic \u03b2\u2010lactamases, such as extended\u2010spectrum \u03b2\u2010lactamases and serine carbapenemases, which may be co\u2010expressed with MBLs and contribute to a multidrug\u2010resistant phenotype. Based on completion of two Phase\u00a03 trials, aztreonam\u2013avibactam was approved in Europe (2024), the United States and China (2025). This Phase\u00a01 open\u2010label study assessed the pharmacokinetics, safety, and tolerability of aztreonam\u2013avibactam in healthy Chinese participants after single\u2010 and multiple\u2010dose administration (doses equivalent to those evaluated in Phase\u00a03 aztreonam\u2013avibactam 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\u2010Chinese participants. Based on population pharmacokinetic modeling which incorporated data from the aztreonam\u2013avibactam Phase\u00a01\u20133 trials, predicted aztreonam and avibactam exposures at steady state for Phase\u00a03 participants in China and non\u2010China (rest\u2010of\u2010world) regions were numerically similar. These findings indicate that aztreonam\u2013avibactam is well tolerated in healthy Chinese adults and support the use of the approved dose regimen by EMA for Chinese patient populations.<\/jats:p>","DOI":"10.1002\/cpdd.70040","type":"journal-article","created":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T09:04:46Z","timestamp":1771491886000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetics of Aztreonam\u2013Avibactam After Single\u2010 and Multiple\u2010Dose Administration: A Phase 1, Open\u2010Label Study in Healthy Chinese Participants and Ethnic Comparison with Non\u2010Chinese Participants"],"prefix":"10.1002","volume":"15","author":[{"given":"Jingjing","family":"Wang","sequence":"first","affiliation":[{"name":"Clinical Pharmacology Research Center Huashan Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinjie","family":"He","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Research Center Huashan Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jufang","family":"Wu","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Research Center Huashan Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Zhang","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Research Center Huashan Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Ma","sequence":"additional","affiliation":[{"name":"Pfizer (China) Research and Development Co., Ltd  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaoqing","family":"Ren","sequence":"additional","affiliation":[{"name":"Pfizer Pharmaceutical Ltd., Development China  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Wei","sequence":"additional","affiliation":[{"name":"Pfizer (China) Research and Development Co., Ltd  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunye","family":"Zhang","sequence":"additional","affiliation":[{"name":"Pfizer (China) Research and Development Co., Ltd  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hua","family":"Zhu","sequence":"additional","affiliation":[{"name":"Pfizer (China) Research and Development Co., Ltd  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan R.","family":"Raber","sequence":"additional","affiliation":[{"name":"Pfizer Research &amp; Development, Pfizer Inc.  San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuangchen","family":"Cong","sequence":"additional","affiliation":[{"name":"Pfizer Pharmaceutical Ltd., Development China  Beijing China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,2,19]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkw231"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/phar.4629"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.1205073109"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1074\/jbc.M113.485979"},{"issue":"2","key":"e_1_2_11_6_1","first-page":"e00047","article-title":"Epidemiology of \u03b2\u2010lactamase\u2010producing pathogens","volume":"33","author":"B","year":"2020","journal-title":"Clin Microbiol Rev"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10096-023-04645-2"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jgar.2023.12.027"},{"key":"e_1_2_11_9_1","unstructured":"Pfizer Inc.Summary of product characteristics: Emblaveo 1.5\u00a0g\/0.5\u00a0g powder for concentrate for solution for infusion.2024. Accessed 8 January 2025.https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/emblaveo\u2010epar\u2010product\u2010information_en.pdf"},{"key":"e_1_2_11_10_1","unstructured":"Pfizer Inc.Highlights of prescribing information: EMBLAVEO (aztreonam and avibactam) for injection for intravenous use. 2025. Accessed April 7 2025.https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2025\/217906Orig1s000lbl.pdf"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/cts.12585"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02105-19"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkz497"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(24)00499-7"},{"key":"e_1_2_11_15_1","volume-title":"Efficacy and safety of aztreonam\u2010avibactam for the treatment of serious infections caused by metallo\u2010\u03b2 lactamase (MBL) producing multidrug resistant Gram\u2010negative bacteria: Phase 3 ASSEMBLE trial","author":"Daikos GL","year":"2024"},{"key":"e_1_2_11_16_1","unstructured":"EdekiT ZhouD van denBergF et\u00a0al.A phase I 3\u2010part placebo\u2010controlled randomised trial to evaluate the safety tolerability and pharmacokinetics of aztreonam\u2010avibactam in healthy subjects. 26th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID);9\u201312 2016;Amsterdam the Netherlands."},{"key":"e_1_2_11_17_1","unstructured":"Pfizer.Pharmacokinetic study of aztreonam\u2010avibactam in severe renal impairment.2023. Accessed January 8 2025.https:\/\/clinicaltrials.gov\/study\/NCT04486625"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00228-023-03609-x"},{"key":"e_1_2_11_19_1","unstructured":"XieR ChanPLS McFadyenLM RaberS.Abstract 990: Development of a simultaneous population pharmacokinetic model for aztreonam\u2010avibactam. 30th European Congress of Clinical Microbiology and Infectious Diseases 2020;Paris France.https:\/\/www.escmid.org\/fileadmin\/escmid\/media\/pdf\/escmid_global_replays\/ECCMID2020abstractbook.pdf"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1128\/aac.01950-24"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-015-0347-x"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jiac.2015.04.006"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/prp2.172"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1128\/aac.00936\u201022"},{"key":"e_1_2_11_25_1","unstructured":"Bristol Myers Squibb Co.AZACTAM\u00ae (aztreonam injection): prescribing information.2018. Accessed January 8 2025.http:\/\/packageinserts.bms.com\/pi\/pi_azactam.pdf"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1124\/dmd.113.055335"},{"key":"e_1_2_11_27_1","unstructured":"Clinical breakpoints for bacteria 2024 European Committee on Antimicrobial Susceptibility Testing"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70040","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70040","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70040","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T12:09:55Z","timestamp":1772971795000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70040"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,2]]},"references-count":26,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2026,2]]}},"alternative-id":["10.1002\/cpdd.70040"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70040","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,2]]},"assertion":[{"value":"2025-08-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-05","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-02-19","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70040"}}