drugset / Trial / NCT00453375

Phase 1 Study of BHT-3021 in Subjects With Type 1 Diabetes Mellitus

NCT00453375 ↗

Phase 1 Completed 80 enrolled Bayhill Therapeutics
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to determine the safety of BHT-3021 injections given weekly for 12 weeks and to evaluate the effect of BHT-3021 on antibody and immune (T cell) responses to autoantigens (e.g. insulin). Changes in pancreatic beta cell function, insulin requirements and blood glucose levels will also be evaluated.

Timeline

Start
2006-10
Primary completion
2011-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject BHT-3021 Unknown — Intramuscular