{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T01:17:03Z","timestamp":1793236623499,"version":"4.5.0"},"reference-count":20,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,4,10]],"date-time":"2026-04-10T00:00:00Z","timestamp":1775779200000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015311","name":"Novartis BioMedical Research","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015311","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cryptosporidiosis is a major diarrheal disease with significant morbidity and mortality in children from low- and middle-income countries. EDI048, a novel Cryptosporidium PI(4)K inhibitor, is designed to act in the gastrointestinal tract and undergo rapid hepatic metabolism to minimize systemic exposure. This study evaluated the safety, tolerability, pharmacokinetics (PK), and effect of food on PK of EDI048 and its metabolites in healthy adult volunteers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In a randomized, placebo-controlled, single and multiple ascending dose trial, healthy adults received EDI048 at 45-, 180-, and 400\u2005mg doses while fasting and a single 400-mg dose in fasted and fed states to evaluate safety and tolerability. Plasma PK was analyzed for EDI048 and 2 inactive metabolites, QPL621 and FRK011.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Fifty-six participants enrolled (single ascending doses, n = 24; multiple ascending doses, n = 24; food effect, n = 8). EDI048 was well tolerated up to 400\u2005mg twice daily for 5.5 days. Few treatment-emergent adverse events occurred, mostly mild and unrelated to study drug. No deaths or drug-related serious adverse events occurred. Dose-proportional exposure was noted for EDI048, QPL621, and FRK011. PK analyses suggested substantial conversion of EDI048 to QPL621. No significant accumulation occurred with multiple dosing. Food intake marginally increased EDI048 exposure. No clinically significant changes in electrocardiogram, laboratory, or vital sign parameters were observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>EDI048 had an acceptable safety profile at all doses tested, up to 400\u2005mg orally administered twice daily for 5.5 days. PK analysis showed minimal systemic exposure of EDI048 in healthy adults. These results support further clinical development for cryptosporidiosis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Trials Registration<\/jats:title>\n                    <jats:p>NCT05275855.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiag210","type":"journal-article","created":{"date-parts":[[2026,4,9]],"date-time":"2026-04-09T11:43:08Z","timestamp":1775734988000},"source":"Crossref","is-referenced-by-count":3,"title":["A First-in-Human Phase 1 Clinical Study in Healthy Volunteers to Assess the Safety, Tolerability, and Pharmacokinetics of EDI048, a Novel Promising Agent to Treat Enteric Cryptosporidiosis"],"prefix":"10.1093","author":[{"given":"Monish","family":"Jain","sequence":"first","affiliation":[{"name":"Biomedical Research, Novartis , Cambridge, Massachusetts 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