{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T19:02:39Z","timestamp":1773342159931,"version":"3.50.1"},"reference-count":27,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T00:00:00Z","timestamp":1771459200000},"content-version":"vor","delay-in-days":18,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T00:00:00Z","timestamp":1769904000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Gantenerumab, a monoclonal antibody targeting amyloid beta plaques in the brain, reduces plaque accumulation and was developed to slow Alzheimer's disease progression. Results from the pivotal GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimer's disease were announced in 2022. The studies did not meet their primary endpoint of slowing clinical decline. This study evaluated the pharmacokinetics, immunogenicity, and safety of a high concentration liquid formulation of gantenerumab administered subcutaneously as a single dose using an autoinjector (AI) or a disposable syringe (DS). The DS was employed in pivotal clinical trials, while the AI was developed in parallel to ease SC administration. The study aimed to demonstrate bioequivalence (BE) between AI and DS administration in healthy participants, defined by 90% confidence intervals (CIs) for geometric least square (LS) mean ratios being within the 0.80\u20101.25 range for maximum observed plasma concentration (C\n                    <jats:sub>max<\/jats:sub>\n                    ) and area under the plasma concentration\u2013time curve (AUC). Among the 266 healthy participants, 135 received 255\u00a0mg gantenerumab via AI and 131\u00a0received 255\u00a0mg via DS in a parallel group design. BE between AI and DS SC administration was demonstrated with geometric LS mean ratios (90% CIs) for C\n                    <jats:sub>max<\/jats:sub>\n                    , AUC\n                    <jats:sub>0\u2010inf<\/jats:sub>\n                    , and AUC\n                    <jats:sub>0\u2010last<\/jats:sub>\n                    of 1.078 (1.006, 1.155), 1.053 (0.986, 1.124), and 1.054 (0.992, 1.121), respectively, all within the 0.80\u20101.25 BE range. Safety findings were consistent with the known safety profile of gantenerumab.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70038","type":"journal-article","created":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T09:11:09Z","timestamp":1771492269000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Bioequivalence Between a Gantenerumab Disposable Syringe and an Autoinjector: A Randomized Controlled Trial in Healthy Volunteers"],"prefix":"10.1002","volume":"15","author":[{"given":"Dietmar","family":"Schwab","sequence":"first","affiliation":[{"name":"Pharma Research and Early Development, Pharmaceutical Sciences Roc he Innovation Center  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carsten","family":"Hofmann","sequence":"additional","affiliation":[{"name":"Pharma Research and Early Development, Pharmaceutical Sciences Roc he Innovation Center  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicole","family":"Justies","sequence":"additional","affiliation":[{"name":"Pharma Research and Early Development, Pharmaceutical Sciences Roc he Innovation Center  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel S.","family":"Dickerson","sequence":"additional","affiliation":[{"name":"ICON \u2013 Early Development Services  Lenexa KS USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ali","family":"Keshavarz","sequence":"additional","affiliation":[{"name":"ICON \u2013 Early Development Services  Lenexa KS USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thijs","family":"van Iersel","sequence":"additional","affiliation":[{"name":"ICON \u2013 Early Development Services  Groningen The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kimberly","family":"Martens","sequence":"additional","affiliation":[{"name":"ICON \u2013 Early Development Services  Lenexa KS USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beate","family":"Bittner","sequence":"additional","affiliation":[{"name":"Global Pharma Strategy Product Optimization  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,2,19]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.12328"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.2174\/156720510791162430"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/alz.70192"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591-022-02062-0"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.3233\/JAD-2011-110977"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13195-019-0559-z"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2020.68"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1001\/archneurol.2011.1538"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.14283\/jpad.2024.60"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2214-109X(24)00264-X"},{"key":"e_1_2_10_12_1","unstructured":"World Health Organization.Dementia fact sheet [resource on the Internet]. Published 2025. Accessed July 29 2025.https:\/\/www.who.int\/en\/news\u2010room\/fact\u2010sheets\/detail\/dementia"},{"issue":"4","key":"e_1_2_10_13_1","doi-asserted-by":"crossref","DOI":"10.1002\/alz.084237","article-title":"Evaluating the safety of anti\u2010amyloid monoclonal antibody infusions in alternative sites of care","volume":"20","author":"Miller C","year":"2024","journal-title":"Alzheimer's Dement"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2304430"},{"issue":"1","key":"e_1_2_10_15_1","doi-asserted-by":"crossref","first-page":"9","DOI":"10.1056\/NEJMoa2212948","article-title":"Lecanemab in early Alzheimer's disease","volume":"388","author":"van Dyck CH","year":"2022","journal-title":"N Engl J Med"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2023.13239"},{"key":"e_1_2_10_17_1","unstructured":"FDA Accepts LEQEMBI\u00ae (lecanemab\u2010irmb) biologics license application for subcutaneous maintenance dosing for the treatment of early Alzheimer's disease.https:\/\/www.prnewswire.com\/news\u2010releases\/fda\u2010accepts\u2010leqembi\u2010lecanemab\u2010irmb\u2010biologics\u2010license\u2010application\u2010for\u2010subcutaneous\u2010maintenance\u2010dosing\u2010for\u2010the\u2010treatment\u2010of\u2010early\u2010alzheimers\u2010disease\u2010302349842.html"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2019.11.015"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.2535"},{"key":"e_1_2_10_20_1","unstructured":"ClinicalTrials.gov.Relative bioavailability of gantenerumab produced by G4 process versus G3 process following subcutaneous injection in healthy participants. 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