{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T16:50:16Z","timestamp":1787503816806,"version":"build-2736575974"},"reference-count":29,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"12","license":[{"start":{"date-parts":[[2022,10,4]],"date-time":"2022-10-04T00:00:00Z","timestamp":1664841600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatol Commun"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    AB\u2010506 is a potent, pan\u2010genotypic small molecule capsid inhibitor that inhibits hepatitis B virus (HBV) pregenomic RNA encapsidation. We assessed the safety, pharmacokinetics, and antiviral activity of AB\u2010506 in two randomized, double\u2010blinded Phase 1 studies in healthy subjects (HS) and subjects with chronic HBV infection (CHB). Single ascending and multiple doses of AB\u2010506 or placebo (30\u20131000\u2009mg or 400\u2009mg daily for 10\u2009days) were assessed in HS. AB\u2010506 or placebo was assessed at either 160\u2009mg or 400\u2009mg daily for 28\u2009days in subjects with CHB. A second follow\u2010up study examined AB\u2010506 or placebo at 400\u2009mg daily for 28\u2009days in 14 Caucasian and 14 East\u2010Asian HS. Twenty\u2010eight days of AB\u2010506 at 160\u2009mg and 400\u2009mg produced mean HBV\u2010DNA declines from baseline of 2.1 log\n                    <jats:sub>10<\/jats:sub>\n                    IU\/ml and 2.8 log\n                    <jats:sub>10<\/jats:sub>\n                    IU\/ml, respectively. Four subjects with CHB (all Asian) had Grade 4 alanine aminotransferase (ALT) elevations (2 at each dose) as HBV DNA was declining; three events led to treatment discontinuation. In the second follow\u2010up study, 2 Asian HS had serious transaminitis events leading to treatment and study termination. No subjects had bilirubin elevations or signs of hepatic decompensation.\n                    <jats:italic toggle=\"yes\">Conclusion<\/jats:italic>\n                    : AB\u2010506 demonstrated mean HBV\u2010DNA declines of &gt;2 log\n                    <jats:sub>10<\/jats:sub>\n                    ; however, transient but severe ALT flares were observed in 4 Asian subjects with CHB. In the follow\u2010up study in HS, 2 additional Asian HS had Grade 4 flares, suggesting that AB\u2010506 hepatotoxicity contributed to the ALT elevations. The AB\u2010506 development program was terminated because of these findings.\n                  <\/jats:p>","DOI":"10.1002\/hep4.2095","type":"journal-article","created":{"date-parts":[[2022,10,4]],"date-time":"2022-10-04T10:43:46Z","timestamp":1664880226000},"page":"3457-3472","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":24,"title":["Safety, pharmacokinetics, and antiviral activity of the capsid inhibitor AB\u2010506 from Phase 1 studies in healthy subjects and those with hepatitis B"],"prefix":"10.1097","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7985-7725","authenticated-orcid":false,"given":"Man\u2010Fung","family":"Yuen","sequence":"first","affiliation":[{"name":"Department of Medicine,University of Hong Kong, Queen Mary Hospital,Hong Kong,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elina","family":"Berliba","sequence":"additional","affiliation":[{"name":"Arensia Exploratory Medicine,Chisinau,Moldova"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wattana","family":"Sukeepaisarnjaroen","sequence":"additional","affiliation":[{"name":"Department of Medicine,Khon Kaen University, Srinagarind Hospital,Khon Kaen,Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3629-4624","authenticated-orcid":false,"given":"Sang Hoon","family":"Ahn","sequence":"additional","affiliation":[{"name":"Department of Medicine,Yonsei University College of Medicine, Severance Hospital,Seoul,Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7634-0843","authenticated-orcid":false,"given":"Tawesak","family":"Tanwandee","sequence":"additional","affiliation":[{"name":"Department of Medicine, Faculty of Medicine,Siriraj Hospital, Mahidol University,Bangkok,Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1544-577X","authenticated-orcid":false,"given":"Young\u2010Suk","family":"Lim","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology,Asan Medical Center,Seoul,Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9141-7773","authenticated-orcid":false,"given":"Yoon Jun","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine,Seoul National University Hospital,Seoul,Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7016-7605","authenticated-orcid":false,"given":"Kittiyod","family":"Poovorawan","sequence":"additional","affiliation":[{"name":"Faculty of Tropical Medicine,Hospital for Tropical Diseases, Mahidol University,Bangkok,Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2926-8671","authenticated-orcid":false,"given":"Pisit","family":"Tangkijvanich","sequence":"additional","affiliation":[{"name":"Center of Excellence in Hepatitis and Liver Cancer,Chulalongkorn University,Bangkok,Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3848-1132","authenticated-orcid":false,"given":"Christian","family":"Schwabe","sequence":"additional","affiliation":[{"name":"New Zealand Clinical Research,Auckland,New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy","family":"Eley","sequence":"additional","affiliation":[{"name":"Clinical Development,Arbutus Biopharma,Warminster,Pennsylvania,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanne","family":"Brown","sequence":"additional","affiliation":[{"name":"Clinical Development,Arbutus Biopharma,Warminster,Pennsylvania,USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9915-6181","authenticated-orcid":false,"given":"Amy C. 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