45
Participants
Start Date
October 24, 2018
Primary Completion Date
October 13, 2021
Study Completion Date
October 13, 2021
AG019 - Low Dose
Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)
Teplizumab
Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
Placebo-AG019
Formulated identically to AG019 with the active ingredient removed.
Placebo-Teplizumab
Formulated identically to teplizumab with the active ingredient removed.
AG019 - High Dose
Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks
AG019 - High Dose
Solid, orally administered capsule - 6 capsules per day for 8 weeks.
UZ Brussel, Brussels
UZ Antwerpen, Edegem
UZ Leuven, Leuven
Barry J Reiner, MD, LLC, Baltimore
University of Miami, Miami
University of South Florida, Tampa
University of Alabama, Birmingham, Birmingham
University Diabetes and Endocrine Consultants, Chattanooga
University of Minnesota Health, Minneapolis
Sanford Children's Specialty Clinic, Sioux Falls
University of Missouri-Kansas City School of Medicine, Kansas City
Research Institute of Dallas, Dallas
Texas Diabetes & Endocrinology, P.A., Austin
University of Colorado, Aurora
Coastal Metabolic Research Centre, Ventura
University of California, San Francisco, San Francisco
Benaroya Research Institute, Seattle
Yale Center for Clinical Investigation, New Haven
Intrexon Actobiotics NV, d/b/a Precigen Actobio
UNKNOWN
Precigen Actobio T1D, LLC
INDUSTRY