SAB-142 for Type 1 Diabetes

(SAFEGUARD Trial)

Recruiting at 60 trial locations

Overseen By Senior Manager Clinical Operations

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: SAb Biotherapeutics, Inc.

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

159 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

This trial is for individuals aged 15-40 diagnosed with Type 1 Diabetes within the last 100 days. They must weigh at least 16 kg and have certain autoantibodies present. Participants need to understand the trial's risks and provide consent. Those misdiagnosed with Type 2 diabetes initially are also eligible if they meet specific criteria.

Inclusion Criteria

My C-peptide level is at least 0.2 nmol/L.

I (or my guardian) have signed and understand the consent form for this study.

I am between 15-40 years old for Part A, or 5-40 years old for Part B.

What Are the Treatments Tested in This Trial?

Interventions

• SAB-142

Trial Overview The study tests SAB-142's ability to halt Type 1 Diabetes progression, comparing a high dose, low dose, and placebo in blinded groups. It assesses safety, efficacy, and tolerability in patients newly diagnosed with Stage 3 of the disease.

How Is the Trial Designed?

Group I: Low Dose SAB-142 Experimental Treatment 1 Intervention

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.

Group II: High Dose SAB-142 Experimental Treatment 1 Intervention

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.

Group III: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

SAb Biotherapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

4,200+