Study ID: Intrexon AG019-T1D-101


Assess the safety and tolerability of different doses of study product administered alone or in association with teplizumab in subjects with clinical recent-onset Type 1 Diabetes Mellitus (T1D). test

Title: A first in human study to assess the safety and tolerability of AG019 and teplizumab for treatment of recent-onset type 1 diabetes mellitus Description: Type 1 diabetes is an autoimmune disease in which beta cells in the pancreas – the cells in the body that create insulin – are broken down by the patient’s own immune system.The sponsor of this study is aiming to stop or delay this autoimmune destruction process by administering two different drugs. One of these drugs is AG019, an oral capsule which consists of living genetically modified bacteria. These bacteria are designed to produce two different proteins involved in the development of type 1 diabetes. The other drug is called teplizumab, this is an immune suppressing agent which is given as an intravenous infusion. 4 Key Inclusion/Exclusion Criteria including Age Range If Applicable: • Male and non-pregnant, non-lactating female patients, aged 12-40 years • Diagnosis of diabetes within 150 days before start of treatment• Positive for autoantibodies characteristic for type 1 diabetes• Stimulated C-peptide following mixed meal tolerance test >0.2 nmol/L (demonstrating that your body can still produce some of its own insulin)
Sioux Falls Region
Principal Investigator:
Kurt Griffin, MD, PhD
Phase I/II
Active - Open to Accrual