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High Dose SAB-142

Phase 2

Type 1 Diabetes | Small molecule | Metabolic |SAB Biotherapeutics, Inc.|Last Updated: Aug 24, 2026

Target and mechanism

Molecular targetthymocyte
Target classProtein
ModalitySmall molecule

Also known as SAB-142

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment159

FDA Designations

No designations recorded

Clinical trial landscape

High Dose SAB-142 · 1 trial · 1 indication

Phase 2 1
NCT07187531SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 DiabetesType 1 Diabetes
RECRUITING159 Analytics
PHASE2RECRUITING
SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes
Type 1 DiabetesUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
From dose administration through Week 4
Part B: Area under the concentration-time curve (AUC) of C-peptide after a 2 hour mixed meal tolerance test (MMTT)
From dose administration up to Month 12

This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln \[AUC+1\] at 12 months)

Part C: Area under the concentration-time curve (AUC) of C-peptide after a 2-hour mixed meal tolerance test (MMTT).
Baseline and Month 24

This is a measure of endogenous insulin production and β-cell function (change from baseline in C-peptide ln \[AUC+1\] at 24 months versus control).

Secondary Endpoints

Time in tight range (TITR)
At baseline, Months 3, 6, 9, 12, 18 and 24
Haemoglobin A1c (HbA1c) levels
At baseline, Months 3, 6, 9, 12, 18 and 24
Time in range (TIR)
At baseline, Months 3, 6, 9, 12, 18 and 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
High Dose SAB-142EXPERIMENTALPart 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. Part C: Long-term efficacy and safety study. Participants continue treatment according to assigned induction dose. Eligible participants who received placebo in Part B and enter Part C will be randomised to active SAB-142 treatment.
Low Dose SAB-142EXPERIMENTALPart 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. Part C: Long-term efficacy and safety study. Participants continue treatment according to assigned induction dose. Eligible participants who received placebo in Part B and enter Part C will be randomised to active SAB-142 treatment.
PlaceboPLACEBO_COMPARATORPart 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.

Interventions

NameTypeDescription
High Dose SAB-142DRUGHigh Dose SAB-142
Low Dose SAB-142DRUGLow Dose SAB-142
PlaceboOTHERPlacebo
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Eligibility Criteria

Age Range5 Years to 40 Years
SexALL
Healthy VolunteersNo
Study Sites70

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 StatesAustraliaAustriaBelgiumDenmarkFinlandFranceGermanyItalyLithuaniaNew ZealandPolandSloveniaSpainUnited Kingdom
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Recent Changes (Last 90 Days)

LOWAug 24, 2026NCT07187531lastUpdatePostDate: changed
LOWAug 24, 2026NCT07187531lastUpdatePostDate: changed
LOWJul 10, 2026NCT07187531lastUpdatePostDate: changed
LOWJul 10, 2026NCT07187531lastUpdatePostDate: changed

Frequently asked questions about High Dose SAB-142

What is High Dose SAB-142 used for in Type 1 Diabetes?

High Dose SAB-142 is an investigational therapy being studied for Type 1 Diabetes (T1D). It is designed to arrest the progression of the disease by targeting thymocytes, a type of protein. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does High Dose SAB-142 target?

High Dose SAB-142 targets thymocyte protein, which is involved in the immune response associated with Type 1 Diabetes. By modulating this target, the therapy aims to preserve pancreatic beta-cell function and slow disease progression. This mechanism is being evaluated in clinical trials for T1D.

Who makes High Dose SAB-142?

High Dose SAB-142 is being developed by SAB Biotherapeutics, Inc., a biopharmaceutical company traded under the ticker symbol SABS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy for Type 1 Diabetes.

What phase is High Dose SAB-142 in?

High Dose SAB-142 is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is recruiting participants to assess its ability to arrest the progression of Type 1 Diabetes.

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 randomized, double-blind, placebo-controlled study is recruiting 159 participants with Type 1 Diabetes across multiple countries, including the United States, Australia, and several European nations.

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

Yes, High Dose SAB-142 is also known as SAB-142. Both names refer to the same investigational drug being developed by SAB Biotherapeutics for the treatment of Type 1 Diabetes. The drug is currently in Phase 2 clinical trials.