Oberschleissheim

Researchers are evaluating SAB-142, a human anti-thymocyte immunoglobulin, in patients with Stage 3 New Onset of Type 1 Diabetes NOT1D. This Phase 2b study aims to assess the safety, tolerability, and effectiveness of SAB-142 in delaying disease progression. The trial includes both an open-label and a double-blind, placebo-controlled study design to compare different doses and placebo effects. The study consists of two parts Part A is an open-label, parallel-arm phase, while Part B is a double-blind, placebo-controlled, parallel-arm phase that begins after Part As completion. Participants receive either a high dose or low dose of SAB-142 or a placebo. The study monitors participants over time to evaluate treatment impact and safety. Participants will undergo various assessments including mixed meal tolerance tests, blood tests for C-peptide and autoantibodies, and continuous glucose monitoring at several time points up to 12 months. Safety is assessed by tracking adverse events through Week 4 in Part A and Month 12 in Part B. The trial measures multiple outcomes related to glucose control, insulin use, and immune response to understand the effects of SAB-142.