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

NCT00453375 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-06-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BHT-3021

Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.

DRUG

BHT-Placebo

Evaluation of up to four dose levels will be given in weekly IM injections for 12 weeks.

Sponsors & Collaborators

  • Bayhill Therapeutics

    lead INDUSTRY

Principal Investigators

  • Peter Gottlieb, MD · University of Colorado, Denver

  • Joanne Quan, MD · Bayhill Therapeutics Inc.

  • Len Harrison, MD · Walter and Eliza Hall Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00453375 on ClinicalTrials.gov