AG019 and Teplizumab

Conditions

Diabetes Mellitus - Type 1

Phase 1B/2

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).

  • Trial with
    Intrexon T1D Partners, LLC
  • Start Date
    10/23/2018
  • End Date
    12/30/2019
Trial Image

For more information about this study, contact:

Linda Ryall

I'm interested in volunteering

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 877.978.8348

  • Last Updated
    08/06/2019
  • Study HIC
    #2000023500