The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants with recent-onset type 1 diabetes (T1D).
This Phase 1b/2a, multi-center study will be conducted in participants with clinical recent-onset type 1 diabetes (T1D). The primary objective of this study is to assess the safety and tolerability of different doses of AG019 alone as well as AG019 in combination with teplizumab. The secondary objectives of this study are: to obtain pharmacodynamic (PD) data of AG019 alone as well as AG019 in combination with teplizumab; and to determine the potential presence of AG019 in systemic circulation (safety - systemic exposure) and the presence of L. lactis bacteria in fecal excretion (local exposure): Pharmacokinetic (PK) profile. This study consists of 2 phases: Phase 1b: this open-label part of the study will investigate the safety and tolerability of 2 different doses of AG019 in 2 age groups (18-40 years of age and 12-17 years of age). Phase 2a: this randomized, double-blind part of the study will investigate the safety and tolerability of AG019, in combination with teplizumab, in 2 age groups (18-40 years of age and 12-17 years of age).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
45
Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)
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).
Formulated identically to AG019 with the active ingredient removed.
University of Alabama, Birmingham
Birmingham, Alabama, United States
University of California, San Francisco
San Francisco, California, United States
Incidence of Treatment-emergent Adverse Events (TEAE)
Treatment-emergent adverse events assessed by the investigator, review of lab reports and information provided by the participant during site visits and/or participant diary with AG019 alone or with teplizumab
Time frame: up to 6 months
AG019 in Systemic Circulation
The presence of live L. lactis bacteria in blood will be assessed by plating
Time frame: Up to 3 months after initiation of the treatment
L. Lactis-secreted hPINS or hIL-10 in Systemic Circulation
The presence of L. lactis-secreted hPINS or hIL-10 in the blood will be assessed by ELISA (enzyme-linked immunosorbent assay)
Time frame: Up to 3 months after initiation of the treatment
AG019 in Feces
The presence of L. lactis (live or dead) in feces will be assessed by Q-PCR (quantitative real-time polymerase chain reaction)
Time frame: Up to 8 days after completion of the treatment
C-peptide Area Under the Concentration-time Curve (AUC) Calculated From a 2 Hour Mixed Meal Tolerance Test (MMTT) at 12 Months
MMTT-stimulated 2-hour C-peptide AUC was defined as the mean area under the C-peptide level time curve over the 2-hour period divided by the duration after a mixed-meal tolerance test.
Time frame: up to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Formulated identically to teplizumab with the active ingredient removed.
Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks
Solid, orally administered capsule - 6 capsules per day for 8 weeks.
Coastal Metabolic Research Centre
Ventura, California, United States
University of Colorado
Aurora, Colorado, United States
Yale Center for Clinical Investigation
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
Barry J Reiner, MD, LLC
Baltimore, Maryland, United States
University of Minnesota Health
Minneapolis, Minnesota, United States
University of Missouri-Kansas City School of Medicine
Kansas City, Missouri, United States
...and 8 more locations