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First-time-in-human randomized clinical trial in healthy volunteers and haemodialysis patients with SNF472: A novel inhibitor of vascular calcification

British Journal of Clinical Pharmacology Oct 06, 2018

Perelló J, et al. - Authors evaluated the safety, tolerability and pharmacokinetics of intravenous (IV) SNF472 (a calcification inhibitor intended to treat cardiovascular calcification in hemodialysis (HD) and in calciphylaxis patients) in this first-time-in-human, double-blind, randomized, placebo-controlled phase 1 trial in healthy volunteers and HD patients. IV SNF472 demonstrated acceptable safety and tolerability and a lack of significant dialysability in this study. For cardiovascular calcification in end-stage renal disease and calciphylaxis, it is a possible novel treatment. In HD patients who received IV SNF472 9 mg kg–1 by 80.0 ± 2.4%, hydroxyapatite crystallization potential was reduced vs placebo, as seen in pharmacodynamic analyses.

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