{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,3]],"date-time":"2026-08-03T17:53:14Z","timestamp":1785779594340,"version":"3.56.0"},"reference-count":16,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T00:00:00Z","timestamp":1768003200000},"content-version":"vor","delay-in-days":9,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>Amyloid\u2010beta (A\u03b2) plaque brain clearance is one of the promising disease\u2010modifying treatment approaches to slow cognitive decline in Alzheimer's disease (AD). ABBV\u2010916, an anti\u2010amyloid antibody, was being developed as an early AD disease\u2010modifying treatment. A phase 1, randomized double\u2010blind, placebo\u2010controlled single ascending dose (SAD) study investigated the safety, tolerability, pharmacokinetics (PK), and immunogenicity of ABBV\u2010916 in healthy participants. Five groups of participants were enrolled and randomized 6:2 to receive ABBV\u2010916 (100, 300, 1000, or 3000\u2009mg) or placebo by intravenous (IV) infusion or subcutaneous (SC) injection (300\u2010mg dose only). After dosing, participants were followed for 20\u2009weeks for assessments. Cerebrospinal fluid (CSF) samples were collected after dosing 1000\u2009mg IV for determination of ABBV\u2010916 levels in the CSF. ABBV\u2010916 single doses up to 3000\u2009mg were well tolerated in healthy participants. No clinically significant laboratory findings, amyloid\u2010related imaging abnormalities, or serious adverse events were reported. The ABBV\u2010916 PK profile exhibited dose\u2010related increases in maximum concentration and area under the plasma concentration\u2010time curve with terminal elimination half\u2010life ranging from 29 to 40\u2009days across the cohorts. The estimated absolute bioavailability after SC dosing was 51%. The average CSF\u2010to\u2010serum partition ratio was 0.12% (range 0.10%\u20130.21%). Positive anti\u2010drug antibody was detected in &lt;\u20097% of participants, which was transient, at low titer, and did not affect ABBV\u2010916 PK. This study demonstrated desirable safety, tolerability, and PK profile of ABBV\u2010916 after single\u2010dose administration in healthy participants. The data supported further evaluation of ABBV\u2010916 multiple IV and SC doses in patients with AD.<\/jats:p>","DOI":"10.1111\/cts.70419","type":"journal-article","created":{"date-parts":[[2026,1,10]],"date-time":"2026-01-10T08:32:05Z","timestamp":1768033925000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety, Tolerability, and Pharmacokinetics of Single Doses of\n                    <scp>ABBV<\/scp>\n                    \u2010916, an Anti\u2010Amyloid Antibody, in Healthy Participants"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0736-2656","authenticated-orcid":false,"given":"Sagar S.","family":"Bachhav","sequence":"first","affiliation":[{"name":"Clinical Pharmacology AbbVie Inc.  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