{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T10:36:31Z","timestamp":1787567791250,"version":"build-2736575974"},"reference-count":36,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,9,6]],"date-time":"2025-09-06T00:00:00Z","timestamp":1757116800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2025,9,6]],"date-time":"2025-09-06T00:00:00Z","timestamp":1757116800000},"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":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Garadacimab is a novel, fully human, anti\u2010activated factor XII monoclonal antibody approved for long\u2010term prophylaxis of patients with hereditary angioedema. This open\u2010label, parallel\u2010group, Phase 1, single\u2010center, bridging study in healthy adults (18\u201355 years of age) characterized the pharmacokinetics and safety of a single 200\u00a0mg subcutaneous injection of garadacimab administered via autoinjector\/pre\u2010filled pen (AI\/PFP) compared with the pre\u2010filled syringe (PFS) used in previous studies. The aim of the study was to bridge the understanding of the PK and safety of garadacimab between PFS and AI\/PFP modes of administration. Participants (N = 132) were stratified by body weight, randomized evenly in six groups by device (AI\/PFP or PFS) and injection site (abdomen, thigh, or upper arm). The primary endpoint comprised pharmacokinetic parameter comparison between devices. Safety\/tolerability were secondary endpoints. The geometric mean ratio (GMR) for C\n                    <jats:sub>max<\/jats:sub>\n                    and AUC\n                    <jats:sub>0\u2013inf<\/jats:sub>\n                    comparing administration by PFS and AI\/PFP was close to 1 with 90% confidence intervals within a range of 0.8\u20131.25, meeting bioequivalence criteria; GMR (90%) was 0.92 (0.81, 1.05) for C\n                    <jats:sub>max<\/jats:sub>\n                    and 0.96 (0.87, 1.07) for AUC\n                    <jats:sub>0\u2013inf<\/jats:sub>\n                    . No participants in this study had anti\u2010drug antibodies against garadacimab. Treatment\u2010related emergent adverse events were reported in 9\/66 (13.6%) participants in the PFS group and 11\/66 (16.7%) participants in the AI\/PFP group. Garadacimab 200\u00a0mg administered as a single subcutaneous dose via AI\/PFP had a consistent safety and tolerability profile to that administered via PFS. These findings support administration of garadacimab via AI\/PFP, providing at\u2010home convenience for patients and physicians.\n                  <\/jats:p>","DOI":"10.1002\/jcph.70099","type":"journal-article","created":{"date-parts":[[2025,9,6]],"date-time":"2025-09-06T09:11:40Z","timestamp":1757149900000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A Phase 1 Randomized Study: Garadacimab Pharmacokinetics, Safety, and Tolerability After Administration via Autoinjector\/Pre\u2010Filled Pen Versus Pre\u2010Filled Syringe in Healthy Participants"],"prefix":"10.1002","volume":"66","author":[{"given":"Fiona","family":"Glassman","sequence":"first","affiliation":[{"name":"CSL Behring LLC  King of Prussia PA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John\u2010Philip","family":"Lawo","sequence":"additional","affiliation":[{"name":"CSL Behring Innovation GmbH  Marburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mihai Alexandru","family":"Bica","sequence":"additional","affiliation":[{"name":"CSL Behring Innovation GmbH  Marburg Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Roberts","sequence":"additional","affiliation":[{"name":"CSL Innovation Pty Ltd.  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