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Nimotuzumab is a humanized antibody that recognizes an extracellular domain III of human EGFR. The aim of this study was to assess the pharmacokinetic behavior of nimotuzumab in patients with ADPKD given as a single dose. A phase I, single\u2010center, and noncontrolled open clinical study was conducted. Five patients were enrolled at each of the following fixed\u2010dose levels: 50, 100, 200, and 400 mg. Intravenous continuous infusions of nimotuzumab were administered every 14 days during a year, except the first administration, when blood samples were drawn during 28 days for pharmacokinetic assessments. Subjects were closely monitored during the trial and at completion of the administration of nimotuzumab, including the anti\u2010idiotypic response. For the first time, nimotuzumab was used for treating a nononcological disease. The administration of nimotuzumab showed dose\u2010dependent kinetics. Nimotuzumab does not develop anti\u2010idiotypic response against the murine portion present in the hypervariable region of the antibody present in the serum of the patients treated. No significant differences were found in the systemic clearance between the 100\u2010 and 400\u2010mg dose, which indicates that the optimal biological dose is in this range of dose.<\/jats:p>","DOI":"10.1002\/jcph.1376","type":"journal-article","created":{"date-parts":[[2019,1,11]],"date-time":"2019-01-11T13:56:10Z","timestamp":1547214970000},"page":"863-871","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Pharmacokinetic Evaluation of Nimotuzumab in Patients With Autosomal Dominant Polycystic Kidney Disease"],"prefix":"10.1002","volume":"59","author":[{"given":"Niurys","family":"de Castro\u2010Su\u00e1rez","sequence":"first","affiliation":[{"name":"Laboratory of Biopharmaceutics Department of Pharmacology &amp; Toxicology Institute of Pharmacy &amp; Foods University of Havana Havana 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