SAB-142 for New Onset Type 1 Diabetes
This study is testing a drug called SAB-142 to see if it can help stop the progression of Type 1 Diabetes (T1D) in people who have recently been diagnosed. Researchers want to find out if SAB-142 is safe and effective. You might receive a high dose of SAB-142, a low dose of SAB-142, or a placebo (an inactive substance like a sugar pill). The study will look at any side effects you might have, and how well your body produces insulin (measured by C-peptide levels) over 12 months. Children and adults aged 5 to 40 years with new onset T1D can participate. The current recruitment status is unclear.
- Study design
- This is a Phase 2b study where neither you nor your doctor will know if you are receiving SAB-142 or a placebo. It aims to enroll 159 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your C-peptide levels will be measured for up to 12 months after receiving the study treatment.
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NCT07187531
SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes
Recruiting
PHASE2Ages 5–40InterventionalSAb Biotherapeutics, Inc.
~159 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:High Dose SAB-142Low Dose SAB-142Placebo
At a glance
Recruiting sites
66 of 70 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Measured over From dose administration through Week 4
+2 more outcomes measured
Conditions
Where it's being run
70 sites across 30 statesUnited Kingdom8
Australia6
New Zealand5
Poland5
Texas4
Austria4
Belgium3
Germany3
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Glutamic acid decarboxylase 65 (GAD65)
Islet antigen 2 (IA-2)
Zinc transporter 8 (ZnT8)
Insulin autoantibodies (if testing within the first 14 days of insulin treatment) 8. Female participants:
Exclusion
Lymphocyte count: \<1000/μL
Neutrophil count: \<1500/μL
Platelet count: \<100 000 platelets/μL
Haemoglobin: \<10 g/dL Note: Specific haematologic, oncologic or other systemic conditions that might otherwise result in exclusion and/or is heretofore unrecognised should be considered in individuals who have one or more blood cell counts below or above the normal ranges. 13. Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) treatment that is known to cause a significant, ongoing change in the course of T1D or immunologic status, including systemic glucocorticoids, verapamil, baricitinib, and others. Note: Inhaled and topical corticosteroids are allowed. Short courses, i.e., approximately 2 weeks or less, of systemic corticosteroids for transient conditions are allowed. 14. Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of drugs other than insulin to treat hyperglycaemia (e.g., metformin, sulfonylureas, glinides, thiazolidinediones, exenatide, liraglutide, glucagon-like peptide 1 agonists \[glucagon-like peptide-1\], dipeptidyl peptidase-4 \[DPP-IV\] inhibitors, or amylin). 15. Current or prior (within 5× half-lives before SV2 for Parts A and B, or within 5x half-lives of Day 1 TP3 for Part C) use of any medication known to significantly influence glucose tolerance (e.g., atypical antipsychotics, diphenylhydantoin, niacin). 16. Current or planned highly restrictive dietary regimen(s) that would interfere with participant well-being or impact to investigational drug. 17. Recent or planned vaccinations as follows:
Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): From 30 days before dosing through 6 months following administration or SAB-142 for each TP.
Recombinant, inactivated or otherwise "non-live" vaccines: From 30 days before dosing or within 60 days following dosing; or planned/required within 30 days prior to or 60 days following Day 1 of TP2.
Live vaccines (e.g., varicella, measles, mumps, rubella, cold-attenuated intranasal influenza vaccine, and smallpox): Within the 30 days before dosing or within 30 days following dosing; or planned/required within 30 days following Day 1 of each TP.
Recombinant, inactivated or otherwise "non-live" vaccines: Within the 30 days before dosing before dosing or within 30 days following dosing; or planned/required within 30 days prior to or 30 days following Day 1 of TP. 18. Female is lactating and/or plans to lactate with the intent to provide her own breast milk to a baby at any point during the study. 19. An individual who has a history of alcohol, drug, or chemical abuse within 12 months prior to study screening (positive tetrahydrocannabinol is allowed) Note: Abuse is defined according to local, regional and/or country specific guidance. Participants who are tested positive for illicit substances but have a prescription medication to manage their concomitant conditions such as attention-deficit/hyperactivity disorder (ADHD) or others are allowed to participate in the study. 20. An individual who has a medical, psychological or social condition that, in the opinion of the Investigator, would interfere with safe and proper completion of the trial. 21. An individual who is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site. 22. An individual who is considered failing to thrive or extremely obese may be excluded based on assessment by the PI, or if participation in the study may place the participant at risk. 23. An individual who has been placed in an institute by official or court order.
What this trial measures
- 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).