{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T23:57:25Z","timestamp":1784246245363,"version":"3.55.0"},"reference-count":10,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T00:00:00Z","timestamp":1693526400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Novartis Pharmaceuticals Corporation"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceutics"],"abstract":"<jats:p>Ligelizumab is a highly potent, humanized IgG1, anti-IgE monoclonal antibody. To explore its optimal subcutaneous delivery, the pharmacokinetics (PK), pharmacodynamics (PD), and tolerability of ligelizumab from two Phase 1 studies in healthy volunteers (HVs) and four Phase 2 and 3 studies in patients with chronic spontaneous urticaria (CSU) were assessed. Using different injection volumes or durations of a liquid-in-vial (LIVI) formulation or different formulations (LIVI vs. prefilled syringe (PFS)), single-dose ligelizumab showed comparable PK exposure in HVs. Steady-state exposure of ligelizumab was also comparable between LIVI and PFS following multiple dosing in CSU patients. The total IgE level (a PD marker) and tolerability were similar between the two formulations in both HVs and patients. Furthermore, the PK, total IgE, and tolerability were comparable for PFS administered either by patients or healthcare providers (HCPs). Collective evidence demonstrated that the injection duration or volume, formulation, or administrator had no apparent impact on the PK, PD, and tolerability of ligelizumab, supporting no clinically relevant difference between LIVI and PFS, and that PFS can be administered by patients or HCPs. This report provides a comprehensive assessment based on data of multiple clinical endpoints from both HVs and patients to inform formulation development and commercial use of a monoclonal antibody.<\/jats:p>","DOI":"10.3390\/pharmaceutics15092266","type":"journal-article","created":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T08:45:31Z","timestamp":1693557931000},"page":"2266","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Comprehensive Assessment of Pharmacokinetics, Pharmacodynamics, and Tolerability of Ligelizumab in Healthy Volunteers and Patients with Chronic Spontaneous Urticaria to Optimize Its Subcutaneous Delivery System"],"prefix":"10.3390","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9569-0574","authenticated-orcid":false,"given":"Yan","family":"Ji","sequence":"first","affiliation":[{"name":"Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudio","family":"Calonder","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research, CH-4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tiina","family":"Kirsil\u00e4","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, CH-4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alis","family":"Burciu","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, CH-4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matjaz","family":"Tisu","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, CH-4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yolandi","family":"Joubert","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, CH-4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nathalie","family":"Laurent","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research, CH-4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Hua","sequence":"additional","affiliation":[{"name":"China Novartis Institutes for Biomedical Research Co., Ltd., Shanghai 201203, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manmath","family":"Patekar","sequence":"additional","affiliation":[{"name":"Novartis Pharma AG, CH-4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anton","family":"Drollmann","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research, CH-4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ralph","family":"Woessner","sequence":"additional","affiliation":[{"name":"Novartis Institutes for Biomedical Research, CH-4056 Basel, Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,9,1]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1038\/s41467-019-13815-w","article-title":"The mechanistic and functional profile of the therapeutic anti-IgE antibody ligelizumab differs from omalizumab","volume":"11","author":"Gasser","year":"2020","journal-title":"Nat. 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