{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T03:21:28Z","timestamp":1788232888196,"version":"build-2803163510"},"reference-count":23,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T00:00:00Z","timestamp":1763683200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T00:00:00Z","timestamp":1763683200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Aligos Therapeutics, Inc., South San Francisco, California, US."}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Antiviral Therapy"],"published-print":{"date-parts":[[2025,12]]},"abstract":"\n Background<\/jats:title>\n Class E (empty) capsid assembly modulators (CAM-Es) inhibit HBV capsid assembly, pregenomic RNA encapsidation preventing formation the establishment of covalently closed circular HBV DNA (ccDNA). ALG-000184 (pevifoscorvir sodium), is a prodrug of the Class E CAM ALG-001075.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n ALG-000184-201 was a Phase 1 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of ALG-000184. Healthy participants (n = 8\/cohort) received oral single-ascending doses (SAD) of ALG-000184 (40, 100, 250, and 500\u00a0mg) or placebo, and multiple-ascending daily doses (MAD) (150\u00a0mg and 250\u00a0mg) or placebo for 7 days.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n ALG-000184 was well tolerated by 48 participants who received single doses up to 500\u00a0mg and multiple daily doses up to 250\u00a0mg for 7 days. ALG-000184 was rapidly converted to the active moiety, ALG-001075. ALG-001075 had dose-proportional increase in plasma exposure, low-to-moderate variability (18%\u201334% CV for AUC\n 0-24<\/jats:sub>\n ), rapid absorption (median t\n max<\/jats:sub>\n 1\u20133.5 h), and biphasic distribution\/elimination with terminal t\u00bd 7\u20138 h and minimal accumulation (\u223c30%). A major oxidative metabolite, ALG-000302, was identified in plasma (\u223c17%\u201324% of ALG-001075). A high-fat\/high-calorie meal did not significantly impact the plasma pharmacokinetics. No differences in pharmacokinetics between Asian and non-Asian participants were observed. A concentration QT analysis indicated no statistically significant change in \u0394\u0394QTcF with plasma ALG-001075. Urinary excretion of ALG-001075 was low following single or multiple ALG-000184 doses.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n ALG-000184 demonstrated good tolerability, safety and pharmacokinetic properties in healthy participants. The pharmacokinetic profile suggests that a daily dose of 100\u00a0mg or higher will provide efficacious exposures in patients with chronic HBV infection.<\/jats:p>\n <\/jats:sec>\n \n Clinical trial number<\/jats:title>\n \n NCT04536337 (\n https:\/\/clinicaltrials.gov\/study\/NCT04536337<\/jats:ext-link>\n ).\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1177\/13596535251392955","type":"journal-article","created":{"date-parts":[[2025,11,21]],"date-time":"2025-11-21T10:25:32Z","timestamp":1763720732000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["A Phase 1 study of the safety, tolerability, and pharmacokinetics of ALG-000184 (pevifoscorvir sodium), a novel Class E capsid assembly modulator, in healthy participants"],"prefix":"10.1177","volume":"30","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4086-7955","authenticated-orcid":false,"given":"Ed","family":"Gane","sequence":"first","affiliation":[{"name":"New Zealand Liver Transplant Unit, University of Auckland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christian","family":"Schwabe","sequence":"additional","affiliation":[{"name":"New Zealand Liver Transplant Unit, University of Auckland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Wu","sequence":"additional","affiliation":[{"name":"Clinical Development, Aligos Therapeutics, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tse-I","family":"Lin","sequence":"additional","affiliation":[{"name":"Research and Development, Aligos Belgium BV"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Blatt","sequence":"additional","affiliation":[{"name":"Clinical Development, Aligos Therapeutics, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Fry","sequence":"additional","affiliation":[{"name":"Clinical Development, Aligos Therapeutics, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sushmita","family":"Chanda","sequence":"additional","affiliation":[{"name":"Clinical Development, Aligos Therapeutics, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5446-819X","authenticated-orcid":false,"given":"Kha","family":"Le","sequence":"additional","affiliation":[{"name":"Clinical Development, Aligos Therapeutics, Inc."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,11,21]]},"reference":[{"key":"e_1_3_8_2_2","unstructured":"WHO. https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/hepatitis-b accessed September 29. 2025."},{"key":"e_1_3_8_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2025.03.018"},{"key":"e_1_3_8_4_2","doi-asserted-by":"publisher","DOI":"10.1002\/hep.28280"},{"key":"e_1_3_8_5_2","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12344"},{"key":"e_1_3_8_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2015.01.002"},{"key":"e_1_3_8_7_2","doi-asserted-by":"crossref","unstructured":"Marcellin P Gane E Buti M et al. 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