{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T19:12:56Z","timestamp":1790709176639,"version":"4.1.0"},"reference-count":30,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2021,8,23]],"date-time":"2021-08-23T00:00:00Z","timestamp":1629676800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Intraoperative ureter identification helps reduce the risk of ureteral injury. Currently, no suitable agents for real\u2010time ureter visualization are approved. ASP5354 (TK\u20101) is a novel indocyanine green derivative. In this first\u2010in\u2010human phase 1, double\u2010blind, sequential ascending\u2010dose study, urethral catheters were placed in 6 healthy volunteers who were randomized to single\u2010dose, intravenous ASP5354 0.1\u00a0mg (n = 4) or placebo (n = 2). Sequential dose escalations to 0.5\u2010, 2\u2010, 8\u2010, and 24\u2010mg ASP5354 in new cohorts were contingent upon Dose\u2010Escalation Committee approval after review of pharmacokinetic (PK) and safety data. Blood and urine samples were collected over 24\u00a0hours following dose administration. Objectives were to assess the safety\/tolerability and PK of ASP5354. Treatment\u2010emergent adverse events (TEAEs) were reported in 3 (15%) and 2 (20%) participants in the ASP5354 and placebo groups, respectively. In the former, there were 6 TEAEs (5\/6 grade 1\u20102). One ASP5354 participant experienced grade 3 pyelonephritis, attributed to the catheter. No TEAEs were related to ASP5354. Mean plasma terminal elimination half\u2010life ranged from 2.1 to 3.6\u00a0hours, with near complete urinary excretion of unchanged ASP5354 within 24\u00a0hours after administration. Linear and dose\u2010proportional PK were observed. These results support further evaluation of ASP5354 at doses up to 24\u00a0mg for intraoperative near\u2010infrared fluorescence ureter visualization.<\/jats:p>","DOI":"10.1002\/cpdd.1013","type":"journal-article","created":{"date-parts":[[2021,8,24]],"date-time":"2021-08-24T06:32:56Z","timestamp":1629786776000},"page":"1460-1468","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Randomized, Double\u2010Blind, Controlled Study to Evaluate Safety and Pharmacokinetics of Single Ascending Doses of ASP5354, an Investigational Imaging Product, in Healthy Adult Volunteers"],"prefix":"10.1002","volume":"10","author":[{"given":"Tosei","family":"Murase","sequence":"first","affiliation":[{"name":"Astellas Pharma Inc  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaomi","family":"Takizawa","sequence":"additional","affiliation":[{"name":"Astellas Pharma Inc  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Galitz","sequence":"additional","affiliation":[{"name":"Labcorp Drug Development Inc.  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