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Therapeutic options for these complement\u2010mediated disorders are limited and sutimlimab, a humanized monoclonal antibody directed against complement factor C1s, may be potentially useful for inhibition of the classical complement pathway. A phase I, first\u2010in\u2010human, double\u2010blind, randomized, placebo\u2010controlled, dose\u2010escalation trial of single and multiple doses of sutimlimab or placebo was conducted in 64 volunteers to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic profiles. Single and multiple infusions of sutimlimab were well tolerated without any safety concerns. sutimlimab exhibited a steep concentration\u2013effect relationship with a Hill coefficient of 2.4, and an IC<jats:sub>90<\/jats:sub> of 15.5 \u03bcg\/mL. This study establishes the foundation for using sutimlimab as a highly selective inhibitor of the classical complement pathway in different diseases.<\/jats:p>","DOI":"10.1002\/cpt.1111","type":"journal-article","created":{"date-parts":[[2018,5,8]],"date-time":"2018-05-08T09:19:01Z","timestamp":1525771141000},"page":"655-663","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":59,"title":["A Randomized, First\u2010in\u2010Human, Healthy Volunteer Trial of sutimlimab, a Humanized Antibody for the Specific Inhibition of the Classical Complement Pathway"],"prefix":"10.1111","volume":"104","author":[{"given":"Johann","family":"Bartko","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology Medical University of Vienna Vienna Austria"},{"name":"Ludwig Boltzmann Institute of Osteology at the Hanusch Hospital of WGKK and AUVA Trauma Centre Meidling 1st Medical Department Hanusch Hospital Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2286-1077","authenticated-orcid":false,"given":"Christian","family":"Schoergenhofer","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Schwameis","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christa","family":"Firbas","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Medical University of Vienna Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Beliveau","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting Montreal Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colin","family":"Chang","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting Montreal Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean\u2010Francois","family":"Marier","sequence":"additional","affiliation":[{"name":"Certara Strategic Consulting Montreal Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darrell","family":"Nix","sequence":"additional","affiliation":[{"name":"Drug Development Consulting"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James C.","family":"Gilbert","sequence":"additional","affiliation":[{"name":"True North Therapeutics Inc. 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