A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).
The SAFEGUARD study aims to evaluate the safety and efficacy of SAB-142 in delaying the onset and progression of T1D, by stopping the body from attacking insulin producing cells (beta cells) in the pancreas. Insulin helps the body regulate blood sugar (glucose). The goal is to help prevent further damage to the body’s insulin producing cells.
Why this Research Matters
The SAFEGUARD study will include a maximum of approximately 159 participants and will last up to around 15 months from the time of screening until the end of the study. The study will involve the following stages: screening, treatment, and follow-up.
Who can Participate
1. 5-40 years old 2. >/= 16 kg 3. Diagnosed with T1D within 100 days 4. At least 1 T1D autoantibody 5. Avoid pregnancy
Study ID
Protocol Number: 25-1807
Meet the Team
Principal Investigator