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drugset / Trial / NCT00927927

First-in-man Trial of NNC0142-0002 in Patients With Rheumatoid Arthritis

NCT00927927 ↗

Phase 1 Completed 65 enrolled Janssen Research & Development, LLC
RandomizedSingle-groupDouble-blindTreatment

Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetic (the effect of the body on the investigated drug) and signs of clinical efficacy of increasing single doses or four repeated doses of NNC 0142-0002 in patients with rheumatoid arthritis.

Timeline

Start
2009-06
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject NNC0142-0002 Unknown 0.0002 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 0.0012 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 0.007 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 0.02 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 0.035 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 0.175 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 0.3 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 0.7 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 1 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 1.6 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 2.5 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 4 mg/kg Subcutaneous
Subject NNC0142-0002 Unknown 7.5 mg/kg Subcutaneous

Indications

rheumatoid arthritis