Oberschleissheim

Researchers are evaluating the safety, tolerability, and effectiveness of SAB-142, a human anti-thymocyte immunoglobulin, in patients with Stage 3 New Onset Type 1 Diabetes (NOT1D). This Phase 2b, randomized, double-blind, placebo-controlled study aims to see if SAB-142 can delay the progression of Type 1 Diabetes in participants aged 5 to 40 years. The study involves comparing high and low doses of SAB-142 against a placebo to assess its impact on disease progression and safety profile. Participants receive either high dose SAB-142, low dose SAB-142, or placebo in parallel arms. The study includes two parts: Part A focuses on safety by monitoring treatment-emergent adverse events through Week 4, while Part B evaluates efficacy by measuring C-peptide levels during a mixed meal tolerance test over 12 months following treatment. The investigational drug is administered according to the study protocol, and participants are closely monitored throughout the treatment periods. During the study, participants undergo regular assessments including blood tests to monitor C-peptide levels and safety labs. Researchers observe adverse events and serious adverse events from treatment start through Week 4, and track the area under the concentration-time curve of C-peptide up to Month 12 to assess beta cell function. Participants must comply with study visits, blood sampling, and other protocol requirements for the full duration of the trial to help researchers understand the treatment's effects and safety.