{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T05:03:08Z","timestamp":1784955788329,"version":"3.55.0"},"reference-count":14,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>ABBV\u2010552, a positive modulator of synaptic vesicle glycoprotein 2A (SV2A), was under investigation as a treatment for cognitive impairment related to Alzheimer's disease. This Phase 1, multicenter, open\u2010label, parallel cohort study (NCT05686980) was conducted to examine the pharmacokinetics (PK), safety, and tolerability of ABBV\u2010552 in healthy adult Japanese and Han Chinese participants and to compare PK and safety findings with healthy adult Western participants from previous studies. Japanese participants in Cohort 1 (N = 10) received three ascending single oral doses (5, 15, and 40\u00a0mg) of ABBV\u2010552 with a washout of 7 days between doses. Han Chinese participants in Cohort 2 (N = 7) received a single oral dose of 40\u00a0mg ABBV\u2010552. After a single oral dose of 40\u00a0mg ABBV\u2010552, PK was comparable between both cohorts. Additionally, the range of individual ABBV\u2010552 concentrations and mean 24\u2010h profiles were comparable with historical data in healthy adult Western participants. In this small study population, single doses of ABBV\u2010552 were well tolerated at all tested doses. Common adverse events reported were dizziness (39%), somnolence (11%), and fatigue (11%). No unique safety signals following single dose ABBV\u2010552 administration were observed in the Japanese or Han Chinese populations examined compared with the previously examined Western population.<\/jats:p>","DOI":"10.1002\/cpdd.70072","type":"journal-article","created":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T05:29:52Z","timestamp":1782970192000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparison of ABBV\u2010552 Safety and Pharmacokinetics in Healthy Asian and Western Adults"],"prefix":"10.1002","volume":"15","author":[{"given":"Nick","family":"Miles","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian","family":"McNamee","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cindy","family":"Zadikoff","sequence":"additional","affiliation":[{"name":"Clinical Development Neuroscience AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joey","family":"Boiser","sequence":"additional","affiliation":[{"name":"Pharmacovigilance and Patient Safety AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamad","family":"Shebley","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ramesh","family":"Boinpally","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc.  North Chicago IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,7,1]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1017\/S1041610203008664"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1001\/jamaneurol.2018.1836"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12582"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2022.1066447"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12035-024-04327-w"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1471-4159.1993.tb03535.x"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.90.6.2150"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.3389\/fnins.2022.864514"},{"key":"e_1_2_9_10_1","unstructured":"MilesN McNamee B. Soleman S. et\u00a0al.Mass balance study of [14C]ABBV\u2010552 in healthy male participants following single oral dose administration. Paper presented at: American College of Clinical Pharmacology; 2025; Minneapolis MN.https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.1588#:~:text=Over%20Study%20Period\u2010 Poster%20Number%3A%20208 \u2010Mass%20Balance%20Study"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/prp2.890"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.gpb.2016.03.008"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2008.141"},{"key":"e_1_2_9_14_1","first-page":"64","volume-title":"Accelerating global drug development: the science and practice of ethnobridging","author":"Jhee S","year":"2006"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.70026"}],"container-title":["Clinical Pharmacology in Drug Development"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70072","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cpdd.70072","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cpdd.70072","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,25]],"date-time":"2026-07-25T04:41:34Z","timestamp":1784954494000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/cpdd.70072"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7]]},"references-count":14,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2026,7]]}},"alternative-id":["10.1002\/cpdd.70072"],"URL":"https:\/\/doi.org\/10.1002\/cpdd.70072","archive":["Portico"],"relation":{},"ISSN":["2160-763X","2160-7648"],"issn-type":[{"value":"2160-763X","type":"print"},{"value":"2160-7648","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7]]},"assertion":[{"value":"2025-12-19","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-07-01","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70072"}}