drugset / Trial / NCT02442557

Safety and Dose-finding Study of DC-TAB in Healthy Subjects

NCT02442557 ↗

Phase 1 Completed 76 enrolled Delta Crystallon BV
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to determine safety and appropriate dose of DC-TAB for selective immune tolerance induction in humans.

Timeline

Start
2009-12
Primary completion
2010-10
Completion
2011-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator recombinant human alpha B-crystallin Protein / enzyme biologic 4 mg Intravenous
Comparator recombinant human alpha B-crystallin Protein / enzyme biologic 10 mg Intravenous
Comparator recombinant human alpha B-crystallin Protein / enzyme biologic 12.5 mg Intravenous
Comparator recombinant human alpha B-crystallin Protein / enzyme biologic 25 mg Intravenous
Comparator recombinant human alpha B-crystallin Protein / enzyme biologic 37.5 mg Intravenous

Indications