Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of R-5280 in newly diagnosed Type 1 Diabetes adolescents
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
9
Edward Jenner Research Group LLC
Plantation, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
UTSW Medical Center
Dallas, Texas, United States
Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance
The number of participants with treatment-related adverse events as evaluated by CTCAE v5.0, will be reviewed to see the results from baseline in toxicology scores at 12 Weeks compared to placebo.
Time frame: 12 Weeks
Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes
To measure the levels of glucose (in milligrams) in the blood at the beginning and again at 12 weeks, and the measurement of C-Peptide (in nanograms) in the blood at the beginning and again at 12 weeks versus placebo, changes in the type of gut bacteria at the beginning and again at 12 weeks versus placebo.
Time frame: 12 Weeks
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