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SAB-142

Phase 3

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

Target and mechanism

Molecular targetthymocyte
Target classProtein
ModalitySmall molecule

Also known as High Dose SAB-142

Success Probability

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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

Frequently asked questions about SAB-142

What is High Dose SAB-142 used for?

High Dose SAB-142 is an investigational small molecule being developed for Type 1 Diabetes (T1D). It is currently in Phase 2 clinical development, with a randomized, double-blind, placebo-controlled trial evaluating its safety and efficacy in arresting the progression of Type 1 Diabetes.

What does High Dose SAB-142 target?

High Dose SAB-142 targets thymocytes, which are a type of protein. The drug is designed to interact with these thymocyte proteins as part of its mechanism of action in treating Type 1 Diabetes. This targeting is being studied in clinical trials to assess its potential to halt disease progression.

Who makes High Dose SAB-142?

High Dose SAB-142 is developed by SAB Biotherapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol SABS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Type 1 Diabetes.

What phase is High Dose SAB-142 in?

High Dose SAB-142 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 trial is currently recruiting participants to study its effects on Type 1 Diabetes progression.

What clinical trials is High Dose SAB-142 in?

High Dose SAB-142 is being studied in a Phase 2 trial with the identifier NCT07187531. This trial is recruiting 159 participants with Type 1 Diabetes across multiple countries, including the United States, Australia, and several European nations. The study is randomized, double-blind, and placebo-controlled.

Is High Dose SAB-142 the same as SAB-142?

Yes, High Dose SAB-142 is also known as SAB-142. The drug is referred to by both names in clinical research and development contexts. It is being investigated for its potential to treat Type 1 Diabetes, with ongoing clinical trials assessing its safety and efficacy.