drugset / Trial / NCT01372137

First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NOX-H94

NCT01372137 ↗

Phase 1 Completed 64 enrolled TME Pharma AG
RandomizedFactorialDouble-blindTreatment

Summary

This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in patients with anemia of chronic disease (inflammation).

Timeline

Start
2011-07
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Lexaptepid pegol Oligonucleotide (other) 0.3 mg/kg Intravenous
Subject Lexaptepid pegol Oligonucleotide (other) 0.6 mg/kg Intravenous
Subject Lexaptepid pegol Oligonucleotide (other) 1.2 mg/kg Intravenous
Subject Lexaptepid pegol Oligonucleotide (other) 2.4 mg/kg Intravenous
Subject Lexaptepid pegol Oligonucleotide (other) 4.8 mg/kg Intravenous

Indications