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NOX-E36 First-in-Human (FIH) Study

TME Pharma AG · 2009
ClinicalTrials.gov · Datasets · License: Public Domain · 2009
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systemic-lupus-erythematosustype-2-diabetes-mellitus
This is the first time NOX-E36 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-E36 is administered by single intravenous (IV) and subcutaneous (SC) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses, dosage regimen and route of administration suitable for multiple dose administration to healthy volunteers, followed by the studies in the patient population.
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