drugset / Trial / NCT00976729

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

NCT00976729 ↗

Phase 1 Completed 72 enrolled TME Pharma AG
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2009-05
Primary completion
2009-12
Completion
2009-12

Drugs

EvaluationDrugModalityDoseRoute
Subject NOX-E36 Aptamer 0.03 mg/kg Intravenous
Subject NOX-E36 Aptamer 0.09 mg/kg Intravenous
Subject NOX-E36 Aptamer 0.25 mg/kg Intravenous
Subject NOX-E36 Aptamer 0.5 mg/kg Intravenous
Subject NOX-E36 Aptamer 1 mg/kg Intravenous
Subject NOX-E36 Aptamer 2 mg/kg Intravenous