{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T22:16:23Z","timestamp":1792880183811,"version":"4.5.0"},"reference-count":42,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2013,12,23]],"date-time":"2013-12-23T00:00:00Z","timestamp":1387756800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2014,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>LBR-101 is a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>The objective of this article is to characterize the safety and tolerability of LBR-101 when administered intravenously to healthy volunteers, by presenting the pooled results of the Phase 1 program.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>LBR-101 was administered to 94 subjects, while 45 received placebo. Doses ranged from 0.2\u2009mg to 2000\u2009mg given once (Day 1), as a single IV infusion, or up to 300\u2009mg given twice (Day 1 and Day 14).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Subjects receiving placebo reported an average of 1.3 treatment-emerging adverse events vs 1.4 per subject among those receiving any dose of LBR-101, and 1.6 in those receiving 1000\u2009mg or higher. Treatment-related adverse events occurred in 21.2% of subjects receiving LBR-101, compared to 17.7% in those receiving placebo. LBR-101 was not associated with any clinically relevant patterns of change in vital signs, ECG parameters, or laboratory findings. The only serious adverse event consisted of \u201cthoracic aortic aneurysm\u201d in a participant later found to have an unreported history of Ehlers-Danlos syndrome.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Single IV doses of LBR-101 ranging from 0.2\u2009mg up to 2000\u2009mg and multiple IV doses up to 300\u2009mg were well tolerated. Overt safety concerns have not emerged. A maximally tolerated dose has not been identified.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/0333102413517775","type":"journal-article","created":{"date-parts":[[2013,12,23]],"date-time":"2013-12-23T23:17:01Z","timestamp":1387840621000},"page":"483-492","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":82,"title":["Safety and tolerability of LBR-101, a humanized monoclonal antibody that blocks the binding of CGRP to its receptor: Results of the Phase 1 program"],"prefix":"10.1177","volume":"34","author":[{"given":"Marcelo E","family":"Bigal","sequence":"first","affiliation":[{"name":"Labrys Biologics Inc., CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafael","family":"Escandon","sequence":"additional","affiliation":[{"name":"Labrys Biologics Inc., CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michele","family":"Bronson","sequence":"additional","affiliation":[{"name":"Labrys Biologics Inc., CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarah","family":"Walter","sequence":"additional","affiliation":[{"name":"Pfizer, Sandwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Sudworth","sequence":"additional","affiliation":[{"name":"Pfizer, Sandwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John P","family":"Huggins","sequence":"additional","affiliation":[{"name":"Pfizer, Sandwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Garzone","sequence":"additional","affiliation":[{"name":"Pfizer WRD, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2013,12,23]]},"reference":[{"key":"bibr1-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1002\/cne.902330410"},{"key":"bibr2-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1016\/0014-5793(86)81338-2"},{"key":"bibr3-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1016\/0169-328X(90)90080-W"},{"key":"bibr4-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1016\/0006-291X(86)90392-X"},{"key":"bibr5-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1016\/S0165-6147(00)01555-8"},{"key":"bibr6-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1016\/S0165-1838(99)00024-7"},{"key":"bibr7-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1177\/1756285610388343"},{"key":"bibr8-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-2796.1990.tb00236.x"},{"key":"bibr9-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1002\/ana.410280213"},{"key":"bibr10-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)61626-8"},{"key":"bibr11-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1177\/0333102411398399"},{"key":"bibr12-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa030505"},{"key":"bibr13-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1038\/clpt.2012.198"},{"key":"bibr14-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1007\/s11940-011-0155-4"},{"key":"bibr15-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198203043060906"},{"key":"bibr16-0333102413517775","first-page":"84","volume":"10","author":"Mould DR","year":"2007","journal-title":"Curr Opin Drug Discov Devel"},{"key":"bibr17-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1016\/j.ymeth.2005.02.001"},{"key":"bibr18-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1521-4141(199908)29:08<2613::AID-IMMU2613>3.0.CO;2-J"},{"key":"bibr19-0333102413517775","doi-asserted-by":"publisher","DOI":"10.1038\/bjp.2008.334"},{"key":"bibr20-0333102413517775","unstructured":"Zeller J, Poulsen KT, Abdiche YN, et al. 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