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EDP\u2010323 is a first\u2010in\u2010class, potent oral selective non\u2010nucleoside inhibitor of the large protein (L polymerase) of RSV under investigation for the treatment of RSV infection. This phase 1, randomized, double\u2010blind, placebo\u2010controlled study evaluated the safety and pharmacokinetics of EDP\u2010323. This study included fasted single ascending dose (SAD; EDP\u2010323 50\/100\/200\/400\/600\/800\u2009mg doses, 3:1 to placebo), fed multiple ascending dose (MAD; EDP\u2010323200\/400\/600\/800\u2009mg doses, 3:1 to placebo), and food effect (EDP\u2010323200\u2009mg dose, 4:1 to placebo) cohorts in healthy adult participants. Key objectives were to assess the safety, tolerability, and pharmacokinetic (PK) profile of EDP\u2010323 in plasma and urine, and to evaluate the effect of food intake on its pharmacokinetics. Among 82 randomized participants (SAD, <jats:italic>n<\/jats:italic>\u2009=\u200950; MAD, <jats:italic>n<\/jats:italic>\u2009=\u200932), EDP\u2010323 was well tolerated up to the highest tested dose (800\u2009mg once daily for 7\u2009days). Adverse events (AEs) were reported in 14.6% of total participants, with the majority being mild and deemed unlikely related to the study drug. Headache was the most frequent AE (<jats:italic>n<\/jats:italic>\u2009=\u20093). PK analysis showed that EDP\u2010323 was rapidly absorbed (<jats:italic>T<\/jats:italic><jats:sub>max<\/jats:sub>\u2009=\u20093.0\u20135.0\u2009h), with exposures increasing with ascending dose. The half\u2010life of EDP\u2010323 (<jats:italic>t<\/jats:italic><jats:sub>1\/2<\/jats:sub>\u2009=\u200910.8\u201316.6\u2009h) supported once\u2010daily dosing, and no food effect was observed. EDP\u2010323 demonstrated a favorable safety and PK profile, supporting its potential as a once\u2010daily oral treatment for RSV.<\/jats:p>","DOI":"10.1111\/cts.70231","type":"journal-article","created":{"date-parts":[[2025,4,28]],"date-time":"2025-04-28T10:16:56Z","timestamp":1745835416000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["<scp>EDP<\/scp>\u2010323, a First\u2010In\u2010Class, Once\u2010Daily, Oral L\u2010Protein Inhibitor for the Treatment of <scp>RSV<\/scp>: Results From a Phase\u00a01 Study in Healthy Adults"],"prefix":"10.1111","volume":"18","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7554-0659","authenticated-orcid":false,"given":"Kimberly","family":"Elmore","sequence":"first","affiliation":[{"name":"Enanta Pharmaceuticals, Inc.  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