{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T09:01:47Z","timestamp":1777453307988,"version":"3.51.4"},"reference-count":42,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T00:00:00Z","timestamp":1757462400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T00:00:00Z","timestamp":1757462400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"General Project of Health Commission of Anhui Province, China","award":["AHWJ2022b014"],"award-info":[{"award-number":["AHWJ2022b014"]}]},{"name":"Clinical Medical Research Transformation Project of Anhui Province, China","award":["202204295107020057"],"award-info":[{"award-number":["202204295107020057"]}]},{"name":"Key Project of Natural Science Research in Universities of Anhui Province, China","award":["2023AH040406"],"award-info":[{"award-number":["2023AH040406"]}]},{"name":"Key Project of Natural Science Research in Universities of Anhui Province, China","award":["2024AH051141"],"award-info":[{"award-number":["2024AH051141"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      RAY1216 is an alpha-ketoamide-based peptide inhibitor of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) major protease (M\n                      <jats:sup>pro<\/jats:sup>\n                      ). This study evaluated the absorption, distribution, metabolism and excretion of [\n                      <jats:sup>14<\/jats:sup>\n                      C]-labelled RAY1216 by oral administration.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Research design and methods<\/jats:title>\n                    <jats:p>\n                      This phase \u0399 study was designed to assess the pharmacokinetics, mass balance and metabolic pathways in 6 healthy Chinese adult men after a single fasting oral administration of 240\u00a0mL (containing 400\u00a0mg\/100\u00a0\u03bcCi) [\n                      <jats:sup>14<\/jats:sup>\n                      C] RAY1216.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      RAY1216 absorbed rapidly in the plasma, with a C\n                      <jats:sub>max<\/jats:sub>\n                      of 1796.83\u00a0ng\/mL, t\n                      <jats:sub>max<\/jats:sub>\n                      of 1.42\u00a0h and t\n                      <jats:sub>1\/2<\/jats:sub>\n                      of 5.97\u00a0h. RAY1216 is mainly excreted through feces and a small amount through urine, indicating that the excretion of RAY1216 occurs through the fecal route, within 96\u00a0h after administration, the majority (&gt;90%) of the radioactive substances were excreted 104.17% of the metabolites were identified in urine and fecal samples. The radioactive transformation pathways suggest that RAY1216 has multiple metabolic pathways, including Oxidation-dealkylation, Mono-oxidation, Hydrolysis, and Urea binding. There were no reports of death, serious adverse events (SAEs), or withdrawals related to SAEs.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The overall recovery rate data of radioactive substances in the excreta of all 6 subjects indicate that favourable mass balance recovery. The overall safety profile is favourable, and it demonstrates promising potential in mitigating both the duration and severity of COVID-19, and the comprehensive clinical safety and therapeutic effect are significantly superior to those of similar COVID-19 treatment drugs. RAY1216 can be referred to and further verified for the Phase II and Phase III clinical trials for the treatment of COVID-19.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/13596535251377204","type":"journal-article","created":{"date-parts":[[2025,9,10]],"date-time":"2025-09-10T07:58:27Z","timestamp":1757491107000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic and mass balance characterization of [\n                    <sup>14<\/sup>\n                    C] RAY1216, a SARS-CoV-2 M\n                    <sup>pro<\/sup>\n                    inhibitor, in healthy Chinese male subjects"],"prefix":"10.1177","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-1755-6394","authenticated-orcid":false,"given":"Wang","family":"Hu","sequence":"first","affiliation":[{"name":"Clinical Trial Research Center, The First Affiliated Hospital of Bengbu Medical University, Bengbu, 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