{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T02:34:28Z","timestamp":1790476468274,"version":"4.1.0"},"reference-count":7,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2022,5,4]],"date-time":"2022-05-04T00:00:00Z","timestamp":1651622400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2022,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Rezafungin is a novel echinocandin being developed for the treatment and prevention of invasive fungal infections. The objectives of this randomized, double\u2010blind study in healthy adults were to determine the safety, tolerability, and pharmacokinetics of rezafungin after subcutaneous (s.c.) administration. The study design consisted of six sequential cohorts of eight subjects, except for the first cohort with four subjects. The subjects were randomized in a 3:1 ratio of rezafungin to placebo and were to receive a single dose of 1, 10, 30, 60, 100, or 200\u2009mg. The most common adverse events (AEs) were increased alanine aminotransferase and sinus bradycardia (unsolicited) and erythema at the injection site (solicited). Unsolicited AEs were generally mild to moderate and not rezafungin\u2010related. Although the study was terminated after the 10\u00a0mg dose cohort due to concerns of potential increased severity of injection site reactions, no predetermined dose escalation halting criteria were met. Following the 10\u00a0mg single s.c. dose of rezafungin (\n                    <jats:italic>n<\/jats:italic>\n                    \u00a0=\u00a06), the geometric mean (GM) maximum concentration (\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    ) was 105.0\u00a0ng\/ml and the median time to\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    was 144\u2009h. The GM area under the concentration\u2010time curve was 32,770\u2009ng*h\/ml. The median estimated terminal half\u2010life was 193\u00a0h. The GM apparent oral clearance was 0.255\u2009L\/h and the GM apparent volume of distribution was 68.5\u00a0L. This study demonstrates that a single s.c. dose of rezafungin in healthy adult subjects: (1) did not result in serious AEs, death, or withdrawal from the study due to an AE; and (2) produced a pharmacokinetic profile with long exposure period postadministration. In an effort to reduce the occurrence of injection site reactions, a re\u2010evaluation of the rezafungin s.c. formulation could be considered in the future.\n                  <\/jats:p>","DOI":"10.1111\/cts.13286","type":"journal-article","created":{"date-parts":[[2022,4,19]],"date-time":"2022-04-19T15:17:23Z","timestamp":1650381443000},"page":"1592-1598","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["A phase I randomized,\n                    <scp>double\u2010blind<\/scp>\n                    , single subcutaneous dose escalation study to determine the safety, tolerability, and pharmacokinetics of rezafungin in healthy adult subjects"],"prefix":"10.1111","volume":"15","author":[{"given":"Kenan","family":"Gu","sequence":"first","affiliation":[{"name":"National Institute of Allergy and Infectious Diseases  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis","family":"Ruff","sequence":"additional","affiliation":[{"name":"ICON Early Phase Services Clinical Research Unit  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cassandra","family":"Key","sequence":"additional","affiliation":[{"name":"ICON Early Phase Services Clinical Research Unit  San Antonio Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marissa","family":"Thompson","sequence":"additional","affiliation":[{"name":"Emmes Company, LLC  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoshanna","family":"Jiang","sequence":"additional","affiliation":[{"name":"Emmes Company, LLC  Rockville Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taylor","family":"Sandison","sequence":"additional","affiliation":[{"name":"Cidara Therapeutics  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shawn","family":"Flanagan","sequence":"additional","affiliation":[{"name":"Cidara Therapeutics  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,5,4]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/jac\/dkx450"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa1380"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00701-16"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01627-16"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.3390\/antibiotics9050227"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/jof6040192"},{"key":"e_1_2_9_8_1","doi-asserted-by":"crossref","first-page":"e0139021","DOI":"10.1128\/AAC.01390-21","article-title":"Metabolism, excretion, and mass balance of [14C]\u2010Rezafungin in animals and humans","volume":"66","author":"Ong V","year":"2021","journal-title":"Antimicrob Agents Chemother"}],"container-title":["Clinical and Translational Science"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.13286","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cts.13286","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cts.13286","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,16]],"date-time":"2023-09-16T15:16:54Z","timestamp":1694877414000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascpt.onlinelibrary.wiley.com\/doi\/10.1111\/cts.13286"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,5,4]]},"references-count":7,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2022,7]]}},"alternative-id":["10.1111\/cts.13286"],"URL":"https:\/\/doi.org\/10.1111\/cts.13286","archive":["Portico"],"relation":{},"ISSN":["1752-8054","1752-8062"],"issn-type":[{"value":"1752-8054","type":"print"},{"value":"1752-8062","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,5,4]]},"assertion":[{"value":"2021-11-08","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-04-04","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-05-04","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}