Principal Investigator: Carla Greenbaum, MD

Phone: 800-877-4187

Email: diabetes@BenaroyaResearch.org

Investigational Product:

BHT-3021 is a DNA vaccine which encodes a protein that is a precursor of human insulin.  After the vaccine is administered, cells at the site of the injection will produce small amounts of this protein.  This protein may teach your immune system that insulin is normal, which may help stop the autoimmune process.

What is the Phase 1 Study of BHT-3021 in Subjects with Type 1 Diabetes?

BHT-3021 is being developed to stop the immune system from destroying the cells in the pancreas which produce insulin. This study will test the safety and possible side effects of BHT-3021.  In addition, this study will evaluate the ability of BHT-3021 to stop or delay the autoimmune process which is damaging the pancreas.

Who can participate?

To be eligible for participation, you must be:

• 18 years of age or older,

• 40 years old or less at the time Type 1 diabetes was diagnosed,

• 5 years or less since T1D was diagnosed.

What do I have to do as a study participant?

If you are eligible and consent to participate in this study, you will be randomly assigned to treatment with the investigational produce, BHT-3021, or a placebo (inactive product).  Participants will come to the clinical center to receive BHT-3021/placebo injection in the muscle in the upper arm weekly for 12 weeks.  Participants will not know what treatment they are receiving until one year after starting the study.  At that time, participants who were treated with placebo will have the option to be treated with BHT-3021.  All participants will be monitored for 12 months after starting tretment with BHT-3021.