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SAB-142

Phase 3

Type 1 Diabetes (T1D) | Small molecule | Metabolic |SAB Biotherapeutics, Inc.|Last Updated: Jun 26, 2026

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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment108
FDA Designations
No designations recorded
Clinical trial landscape

SAB-142 · 1 trial · 1 indication

Phase 3 1
NCT07670650PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) StudyType 1 Diabetes (T1D)
NOT YET_RECRUITING108 Analytics
PHASE3NOT YET_RECRUITING
PRISE (Personalized Response and Immunologic Surveillance of Endogenous C-Peptide Preservation in New, Recent, and Established Onset Type 1 Diabetes Treated With Human Anti-Thymocyte Globulin [h-ATG]) Study
Type 1 Diabetes (T1D)
NCT07670650108
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Study Endpoints
Primary Endpoints
Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT)
Dose administration to 12 Months

This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\].

Secondary Endpoints
AUC of C-peptide after a 2-hour MMTT in a priori in vitro identified "responders" and "non-responders"
Baseline, Months 3, 6, 9 and 12
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Dose administration to 12 Months
To evaluate the pharmacokinetics (PK) of SAB-142
Days 1 and 2 of each treatment period (pre- and post-dose/end of infusion [EOI]), plus Week 1 for TP1 (for participants that attend the optional in-clinic visit), Week 4, and Months 3, and 7.
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SAB-142EXPERIMENTALSAB-142 in recent and established onset T1D
PlaceboPLACEBO_COMPARATORPlacebo Comparator
Interventions
NameTypeDescription
SAB-142DRUGTreatment Period 1 (Induction) Day 1: SAB-142 0.5 mg/kg IV Day 2: SAB-142 2.0 mg/kg IV Treatment Period 2 (Month 6 Maintenance) Day 1: SAB-142 0.5 mg/kg IV Day 2: SAB-142 1.0 mg/kg IV Total induction dose: 2.5 mg/kg Total maintenance dose: 1.5 mg/kg
PlaceboDRUGPlacebo Comparator: Placebo
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Eligibility Criteria
Age Range5 Years to 40 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. Participant and/or appropriate legal guardian for participants below the legal age of consent 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 a...

Countries:United States
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Competitive Landscape -Diabetes Complications 6 trials (matched to "Type 1 Diabetes (T1D)")
CompanyTickerTrialsLead PhaseDrugs
FibroBiologics, Inc.FBLG1PHASE1Undisclosed
MiMedx Group, Inc.MDXG2N/AUndisclosed
Integra LifeSciences Holdings CorporationIART1N/AUndisclosed
Organogenesis Holdings, Inc. Class AORGO1N/AUndisclosed
Healthcare Services Group, Inc.HCSG1N/AUndisclosed
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Recent Changes (Last 90 Days)
LOWJun 26, 2026NCT07670650NEW_TRIAL: changed
LOWJun 26, 2026NCT07670650NEW_TRIAL: changed