NCT07187531

SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: SAb Biotherapeutics, Inc. · Industry
• Sex: All
• Age: 5 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2b, investigator- and participant-blinded, placebo-controlled, parallel-arm study to evaluate the efficacy, safety and tolerability of SAB 142 in patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D).

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	High Dose SAB-142	High Dose SAB-142
DRUG	Low Dose SAB-142	Low Dose SAB-142
OTHER	Placebo	Placebo

Timeline

• Start date: 2025-11-25
• Primary completion: 2027-11-01
• Completion: 2028-12-01
• First posted: 2025-09-23
• Last updated: 2026-02-12

Locations

65 sites across 15 countries: United States, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Lithuania, New Zealand, Poland, Slovenia, Spain, United Kingdom

Regulatory

• FDA-regulated drug study