AG019 and Teplizumab

What is the purpose of this trial?

This Phase 1b/2a, multi-center study will be conducted in subjects with clinical recent-onset Type 1 Diabetes Mellitus (T1D). A maximum of 8 single dose subjects and a maximum of 48 repeat dose subjects will be enrolled in clinical sites in the US and the EU. This study will consist of 2 phases: Phase 1b: this open-label part of the study will investigate the safety and tolerability of different doses of AG019, in 2 age groups (18 years of age and 12-17 years of age, respectively), administered as single or repeat doses. Subjects will be enrolled in 4 sequential cohorts (AG019 cohorts). Phase 2a: this randomized, double-blind part of the study will investigate the safety and tolerability of different doses of AG019, in association with IV teplizumab, in 2 age groups (18 years of age and 12-17 years of age, respectively). Subjects will be enrolled in 2 sequential cohorts (combination cohorts).


Participation Guidelines

Ages: 12 years and older

Gender: Both


Intrexon T1D Partners, LLC

Start Date: 10/24/2018

End Date: 12/31/2019

Last Updated: 10/30/2018

Study HIC#: 2000023500

Get Involved

For more information about this study, contact:
Kristine Tyc
+1 203-737-4697
kristine.tyc@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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