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

NCT07187531 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2026-05-12

No results posted yet for this study

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

Interventions

DRUG

High Dose SAB-142

High Dose SAB-142

DRUG

Low Dose SAB-142

Low Dose SAB-142

OTHER

Placebo

Placebo

Sponsors & Collaborators

  • SAb Biotherapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-25
Primary Completion
2027-11-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Italy
  • Lithuania
  • New Zealand
  • Poland
  • Slovenia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07187531 on ClinicalTrials.gov