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)

SAb Biotherapeutics, Inc.

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).

Eligibility

Age range: 5–40 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Participant and/or appropriate legal guardian must have given written informed consent and/or assent according to local, regional and/or country specific guidance before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. 2. Males and females 15-40 years old at the time of randomisation in Part A. Males and females 5-40 years old\*, inclusive, at the time of randomisation in Part B. 3. Weight ≥16.0 kg at time of randomisation. 4. Participant has received a dia…

Interventions

Drug
High Dose SAB-142
High Dose SAB-142
Drug
Low Dose SAB-142
Low Dose SAB-142
Other
Placebo
Placebo

Locations (65)

University of California San Francisco Benioff Children's Hospital
San Francisco, California
University of Colorado - Barbara Davis Center for Diabetes
Aurora, Colorado
University of Florida College of Medicine
Gainesville, Florida
University of Miami - Gables One Tower
Miami, Florida
Children's Healthcare of Atlanta (CHOA) - Center for Advanced Pediatrics
Atlanta, Georgia
IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & Endocrinology
Indianapolis, Indiana