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

Conditions

• Type 1 Diabetes

Eligibility Criteria

Sex

ALL

Age

5 Years - 40 Years

Healthy Volunteers

Not accepted

Interventions

• High Dose SAB-142 — DRUG
  High Dose SAB-142
• Low Dose SAB-142 — DRUG
  Low Dose SAB-142
• Placebo — OTHER
  Placebo

Study Details

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).

Key Dates

First listed

Sep 23, 2025

Start date

Nov 25, 2025

Status verified

Jul 2026

Primary completion

Nov 30, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

159 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Experimental: High Dose SAB-142
  Part A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.
• Experimental: Low Dose SAB-142
  Part A: Open-label, parallel arm study. Part B: Double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.
• Placebo Comparator: Placebo
  Part B: This is a double-blind, placebo-controlled, parallel-arm study. Enrolment into Part B may commence once all participants in Part A have been randomised.

Primary Outcome Measure

Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) [ Time Frame: From dose administration through Week 4 ]

Central Contacts

• Senior Manager Clinical Operations
  1-844-763-1890
  [email protected]

Locations (23)

Find similar trials in San Francisco, CA

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