SAFety and Efficacy of Human Anti-thymocyte ImmunoGlobUlin SAB-142 ARresting Progression of Type 1 Diabetes (SAFEGUARD)

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Placebo; Drug: High Dose SAB-142; Drug: Low Dose SAB-142

• Study Type: Interventional
• Enrollment (Estimated): 159
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Senior Manager Clinical Operations; Phone Number: 1-844-763-1890; Email: SAFEGUARD@sab.bio

Study Locations

• Australia
  • Brisbane, Australia, 4101
    • Recruiting
    • Queensland Children's Hospital
  • Nedlands, Australia, 6009
    • Not yet recruiting
    • Government of Western Australia - Child and Adolescent Health Service - Perth Children's Hospital
  • Parkville, Australia, 3052
    • Not yet recruiting
    • The Royal Children's Hospital Melbourne
  • Parkville, Australia, 3052
    • Recruiting
    • The Royal Melbourne Hospital (RMH)
  • St Leonards, Australia, 2065
    • Recruiting
    • Royal North Shore Hospital (RNSH)
  • Westmead, Australia, 2145
    • Recruiting
    • Westmead Hospital
• Austria
  • Graz, Austria, 8036
    • Not yet recruiting
    • Medizinische Universitaet Graz - Klinik fuer Innere Medizin
  • Innsbruck, Austria, 6020
    • Not yet recruiting
    • Medizinische Universitat Innsbruck
  • Vienna, Austria, 1090
    • Not yet recruiting
    • Medizinische Universitaet Graz - Universitaetsklinik fuer Kinder und Jugendheilkunde
  • Vienna, Austria, 1090
    • Not yet recruiting
    • Medizinische Universitaet Wien - Universitaetsklinik fuer Kinder und Jugendheilkunde
• Belgium
  • Jette, Belgium, 1090
    • Not yet recruiting
    • Universitair Ziekenhuis Brussel
  • Leuven, Belgium, 3000
    • Not yet recruiting
    • UZ Leuven
  • Liège, Belgium, 4000
    • Not yet recruiting
    • Groupe sante CHC - Clinique du MontLegia
• Denmark
  • Herlev, Denmark, 2730
    • Not yet recruiting
    • Steno Diabetes Center
• Finland
  • Helsinki, Finland, 00029
    • Not yet recruiting
    • Helsingin yliopistollinen keskussairaala
  • Turku, Finland, 20521
    • Not yet recruiting
    • Turun Yliopistollinen Keskussairaala (TYKS)
• France
  • Paris, France, 75014
    • Not yet recruiting
    • Universite Paris Descartes - Institut Cochin
  • Paris, France, 75019
    • Not yet recruiting
    • Assistance Publique-Hopitaux de Paris (AP-HP) - Hopital Universitaire Robert-Debre
• Germany
  • Augsburg, Germany, 86156
    • Not yet recruiting
    • Klinikum Augsburg
  • Hanover, Germany, 30173
    • Not yet recruiting
    • Hannoversche Kinderheilanstalt
  • Oberschleißheim, Germany, 85764
    • Not yet recruiting
    • Technische Universität Munich
• Italy
  • Milan, Italy, 20132
    • Not yet recruiting
    • IRCCS Ospedale San Raffaele
  • Turin, Italy, 28100
    • Not yet recruiting
    • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
  • Verona, Italy, 37126
    • Not yet recruiting
    • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale della Donna e del Bambino_Borgo Trento
• Lithuania
  • Kaunas, Lithuania, 50161
    • Not yet recruiting
    • Hospital of Lithuanian University of Health Sciences Kauno Klinikos
• New Zealand
  • Auckland, New Zealand, 0620
    • Recruiting
    • Waitemata District Health Board- North Shore Hospital
  • Christchurch, New Zealand, 8011
    • Recruiting
    • New Zealand Clinical Research - Christchurch
  • Dunedin, New Zealand, 9016
    • Not yet recruiting
    • Dunedin Hospital
  • Hamilton, New Zealand, 3204
    • Not yet recruiting
    • Waikato Hospital
  • Wellington, New Zealand, 6021
    • Not yet recruiting
    • Wellington Regional Hospital
  • Auckland
    • Auckland, Auckland, New Zealand, 1640
      • Recruiting
      • Aotearoa Clinical Trials
• Poland
  • Opole, Poland, 46-020
    • Not yet recruiting
    • Uniwersytecki Szital Klniczny w Opolu
  • Poznan, Poland, 60-572
    • Not yet recruiting
    • SZPITAL KLINICZNY im. Karola Jonschera - UNIWERSYTETU MEDYCZNEGO im. Karola Marcinkowskiego
  • Warsaw, Poland, 02-117
    • Not yet recruiting
    • Instytut Diabetologii
  • Warsaw, Poland, 02-091
    • Not yet recruiting
    • Warszawski Uniwersytet Medyczny - Klinika Pediatrii
  • Warsaw, Poland, 02-172
    • Not yet recruiting
    • MTZ Clinical Research Sp. z o.o.
• Slovenia
  • Ljubljana, Slovenia, 1525
    • Not yet recruiting
    • University Children's Hospital Ljubljana (UCHL)
• Spain
  • Barakaldo, Spain, 48903
    • Not yet recruiting
    • Hospital de Cruces
  • Málaga, Spain, 29010
    • Not yet recruiting
    • Hospital Universitario Virgen de la Victoria
  • Seville, Spain, 41009
    • Not yet recruiting
    • Hospital Universitario Virgen Macarena
• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
    • Not yet recruiting
    • Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
  • Cardiff, United Kingdom, CF14 4XW
    • Not yet recruiting
    • Noahs Ark Childrens Hospital for Wales
  • Edinburgh, United Kingdom, EH9 1LF
    • Not yet recruiting
    • NHS Lothian - Royal Hospital for Sick Children
  • Liverpool, United Kingdom, L12 2AP
    • Not yet recruiting
    • Alder Hey Children's NHS Foundation Trust
  • London, United Kingdom, E1 1BB
    • Recruiting
    • Barts Health NHS Trust - The Royal London Hospital
  • London, United Kingdom, NW1 2PG
    • Not yet recruiting
    • University College London Hospitals NHS Foundation Trust - University College Hospital
  • Nottingham, United Kingdom, NG7 2UH
    • Not yet recruiting
    • Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)
  • Oxford, United Kingdom, OX3 9DU
    • Not yet recruiting
    • Oxford University Hospitals NHS Trust - John Radcliffe Hospital
• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California San Francisco Benioff Children's Hospital
    • San Jose, California, United States, 95128
      • Recruiting
      • San Jose Clinical Trials, LLC
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado - Barbara Davis Center for Diabetes
  • Florida
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida College of Medicine
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • University of Miami - Gables One Tower
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Recruiting
      • Children's Healthcare of Atlanta (CHOA) - Center for Advanced Pediatrics
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & Endocrinology
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Not yet recruiting
      • Harvard Medical School - Joslin Diabetes Center and Joslin Clinical (JDS)
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Children's Mercy Hospital Kansas - Pediatric Care Clinic
  • New York
    • Buffalo, New York, United States, 14203
      • Not yet recruiting
      • University at Buffalo MD Physicians Group
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • Recruiting
      • N.C. Children's Hospital - Children's Specialty Clinics - Chapel Hill at Carolina Pointe II
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Not yet recruiting
      • Sanford Medical Center Fargo
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • The Children's Hospital of Philadelphia
  • Texas
    • Fort Worth, Texas, United States, 76104
      • Not yet recruiting
      • Cook Children's Medical Center
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • Texas Children's Hospital - Clinical Care Center - Pediatric Renal Clinic
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Not yet recruiting
      • University of Virginia Health System - Pediatric Diabetes Clinic
  • Washington
    • Seattle, Washington, United States, 98101
      • Recruiting
      • Benaroya Research Institute at Virginia Mason
    • Tacoma, Washington, United States, 98405-3720
      • Not yet recruiting
      • Mary Bridge Children's Outpatient Center - Tacoma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 diagnosis of T1D according to American Diabetes Association criteria within 100 days of randomization. For participants who were initially misdiagnosed with Type 2 diabetes, time from misdiagnosis with Type 2 diabetes to randomization is 100 days. Note: The date of diagnosis is defined as the date of the first insulin dose or any other glucose lowering medication. An extension of no more than 14 days is permitted if a participant has planned and/or is required to receive a vaccination within 30 days prior to randomisation or is completing the 10 day CGM period.
5. Participant has random C-peptide levels of ≥0.2 nmol/L, measured during Screening. One random C-peptide retest during screening period is allowed.
6. Participant completed all scheduled samples for C-peptide collected during the MMTT test during Screening.

7. Participant has a positive result on testing for at least one of the following T1D-related autoantibodies during screening:

   • 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:

   a. Must be of nonchildbearing potential, i.e., pre-pubertal*, surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening, or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or b. If of childbearing potential, must: i. Have a negative result on a serum (beta human chorionic gonadotropin [β-HCG]) at screening and a negative urine β-HCG pregnancy test prior to study drug administration on Day 1 of both treatment periods.

   ii. Agree not to become pregnant or donate ova from signing the consent form until the end of study visit.

   iii. If not exclusively in a same-sex relationship or abstinent as a committed lifestyle, must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception from signing the consent and for the duration of the study.

   * Note: Female participants will be considered to be pre-pubertal (and of nonchildbearing potential) if they have not yet started menstruation. This should also be verified by the parent(s)/guardian(s). If a female participant reaches menarche during the study, then she is to be considered as a woman of childbearing potential from that time forwards, and contraceptive requirements will apply.

9. Male participants, if not biologically or surgically sterilised, must:

   1. Agree not to donate sperm from signing the consent form until EOS.
   2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception from signing the consent form until EOS.
   3. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from signing the consent form until EOS.
10. Prior to receiving study drug, participant must agree to receive locally, regionally and/or country-specific required age-appropriate immunisations. Participants are advised but not required to comply with the guidelines for immunosuppressed individuals and those with chronic disease (diabetes mellitus) according to current local, regional and/or country- specific guidelines. Note: Vaccines are permitted within the timeframes specified in exclusion criterion #17.
11. Participant agrees not to receive other forms of experimental treatment from the time of signing informed consent and for the duration of the study, particularly agents that may be immune modulatory in nature and/or stimulate pancreatic β cell regeneration or insulin secretion.
12. Participant has suitable venous access for blood sampling.
13. Participant is willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.

Exclusion Criteria:

1. Participant has known allergy, hypersensitivity or moderate to severe allergic reaction including anaphylaxis to natural or recombinant antibodies, biologic treatments, passive vaccines, pork, or any other component of the study drug formulation (including biologic medications).
2. Participant has a known allergy or hypersensitivity to any of the protocol-required concomitant medications.
3. Participant has been an active participant in a therapeutic drug, invasive medical device, or vaccine clinical trial within 12 weeks before Screening Visit (SV)2.
4. Participant has received teplizumab or any investigational immunomodulatory anti-CD3 treatment within any timeframe prior to screening.
5. Participant has a significant uncontrolled renal, cardiac, vascular, pulmonary, gastrointestinal, neurologic, haematologic, rheumatologic, oncologic, psychiatric, or immune deficiency that may interfere with the participant's safely participating in the study or with interpretation of the safety and/or efficacy profile of investigational medicinal product (IMP). For any disorders, a participant with a stable, well-controlled condition that is not felt to interfere with study participation may be enrolled.
6. Participant has any autoimmune disease other than T1D (e.g., latent autoimmune diabetes in adults, rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythaematous) that is currently managed with systemic immunotherapy, with the exception of clinically stable thyroid or celiac disease.
7. Participant is prone to infections, or has chronic, recurrent or opportunistic infectious disease, including but not limited to renal, respiratory or skin infections, Pneumocystis carinii, aspergillosis, latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.
8. Participant has a history of or serologic evidence at screening of current or past infection with human immunodeficiency virus (HIV)-1 or 2, hepatitis B virus (HBV), or hepatitis C virus (HCV) antibodies.
9. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (posterior anterior and lateral), and/or TB testing. Note: Blood testing (e.g., QuantiFERON® TB Gold test) is strongly preferred; if not available, any local approved TB test is allowed.
10. Serious systemic viral, bacterial, or fungal infection (e.g., pneumonia, pyelonephritis), infection requiring hospitalization or IV anti-infective treatments or significant acute or chronic viral (including history of recurrent or active herpes zoster, acute or active cytomegalovirus [CMV], Epstein-Barr Virus [EBV] as determined at screening), bacterial, or fungal infection (e.g., osteomyelitis) 30 days before and during screening. Note: Participants with confirmed active EBV or CMV infection based on polymerase chain reaction (PCR) test can be retested; asymptomatic participants with the most recent PCR-negative test are eligible for participation. Participants with an active mild infection at Screening may be enrolled once the symptoms have resolved and all I/E are met. Participants who have an active infection and/or fever ≥38.0°C (100.4°F) within the 48 hours prior to dose administration should not be dosed.
11. Participant has a diagnosis of significant liver disease or at screening ALT and/or AST >2× or total bilirubin of >1.5× of the age- and sex-specific upper limit of normal (ULN) according to the central laboratory and confirmed by repeated tests. Liver function tests can be repeated during screening and if normalised, participant maybe eligible for randomization. Note: Participants with Gilbert's syndrome are allowed to enrol if only total and/or indirect bilirubin are elevated above ULN while ALT, AST, and alkaline phosphatase (ALP) are within the normal laboratory ranges.

12. An individual has any of the following haematologic parameters, confirmed by repeat tests, during Screening:

    • 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) 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) 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) 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): Within the 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.
    • Recombinant, inactivated or otherwise "non-live" vaccines: Within the 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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose SAB-142; Part 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.	Drug: High Dose SAB-142; High Dose SAB-142
Experimental: Low Dose SAB-142; Part 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.	Drug: Low Dose SAB-142; Low Dose SAB-142
Placebo Comparator: Placebo; Part 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.	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	This is a measure of endogenous insulin production and β cell function (change from baseline in C-peptide ln [AUC+1] at 12 months)	From dose administration up to Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part B: Time in tight range (TITR)	Expressed as a daily average of the percentage of time in a 24hour day a participant's glucose is >70 but ≤140 mg/dL (>3.9 to ≤7.8 mmol/L), assessed using continuous glucose monitoring (CGM)	At baseline, Months 3, 6, 9 and 12
Part B: Haemoglobin A1c (HbA1c) levels	Expressed in % and mmol/mol	At baseline, Months 3, 6, 9 and 12
Part B: Time in range (TIR)	Expressed as a daily average of the percentage of time in a 24-hour day a participant's CGM reading is >70 but ≤180 mg/dL (>3.9 to ≤10.0 mmol/L), assessed by CGM	At baseline, Months 3, 6, 9 and 12
Part B: Time above range, assessed by CGM		At baseline, Months 3, 6, 9 and 12
Part B: Time below range, assessed by CGM		At baseline, Months 3, 6, 9 and 12
Part B: Exogenous insulin use	Defined as a daily average in units per kilogram per day (U/kg/day) (total daily insulin based on participant's diary at predefined study periods)	At baseline, Months 3, 6, 9 and 12
Part B: Number of clinically important episodes	Defined as the total number of Level 2 and 3 hypoglycaemic events and/or episodes of cognitive impairment requiring external assistance for recovery (participant's diary and CGM-based)	At baseline, Months 3, 6, 9 and 12
Part B: Proportion of participants with partial clinical remission	Defined as an insulin requirement of <0.25 units per kg of body weight per day and HbA1c <6.5% (47 mmol/mol)	At baseline, Months 3, 6, 9 and 12
Part B: Proportion of participants with partial remission	Defined as insulin-dose adjusted A1c (IDAA1c) + [4 × insulin dose (units per kilogram per 24 h) ≤9	At baseline, Months 3, 6, 9 and 12
Part B: Total BETA-2 score, comprised of fasting plasma glucose (mmol/L), HbA1c (%), daily insulin (U/kg), and fasting C-peptide (nmol/L)		At baseline, Months 3, 6, and 12
Part B: Insulin dose-adjusted A1c (IDAA1C)		At baseline, Months 3, 6, 9 and 12
Part B: Incidence of TEAEs, AESIs, and SAEs		From dose administration through Month 12
Part B: SAB-142 serum concentrations		Days 1 and 2 of each treatment period (pre- and post- dose/end of infusion [EOI]), plus Weeks 1, 4, and Months 3, 6, and 7
Part B: Incidence of anti-SAB-142 antibodies including optional neutralising antibodies (nAbs) in serum		At baseline, Week 4, Months 3, 6, 7, 9 and 12
Part B: Titres of anti-SAB-142 antibodies including optional neutralising antibodies (nAbs) in serum		At baseline, Week 4, Months 3, 6, 7, 9 and 12
Part B: Immunophenotyping (IPT)		At baseline (Day 1, pre-dose), Week 4, Months 3, 6, 7, 9 and 12

Collaborators and Investigators

• Sponsor: SAb Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: September 8, 2025
• First Submitted That Met QC Criteria: September 15, 2025
• First Posted (Actual): September 23, 2025

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: SAB-142-201; 2025-521560-36-00 (Ctis); U1111-1320-2651 (Other Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No