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

Part of paid clinical trials in San Francisco, California.

Sponsor
SAb Biotherapeutics, Inc.
Study ID
NCT07187531
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
5 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • High Dose SAB-142 — DRUG
    High Dose SAB-142
  • Low Dose SAB-142 — DRUG
    Low Dose SAB-142
  • Placebo — OTHER
    Placebo

Study Details

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).

Key Dates

Start date
Nov 25, 2025
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
159 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Part A: Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) [ Time Frame: From dose administration through Week 4 ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
University of California San Francisco Benioff Children's HospitalSan FranciscoCalifornia94158-
San Jose Clinical Trials, LLCSan JoseCalifornia95128-
University of Colorado - Barbara Davis Center for DiabetesAuroraColorado80045-
University of Florida College of MedicineGainesvilleFlorida32610-
University of Miami - Gables One TowerMiamiFlorida33136-
Children's Healthcare of Atlanta (CHOA) - Center for Advanced PediatricsAtlantaGeorgia30329-
IUH - Riley Hospital for Children - Riley Outpatient Center - Pediatric Diabetes & EndocrinologyIndianapolisIndiana46202-
Harvard Medical School - Joslin Diabetes Center and Joslin Clinical (JDS)BostonMassachusetts02215-
Children's Mercy Hospital Kansas City - Pediatric Care ClinicKansas CityMissouri64111-
University of New Mexico HospitalAlbuquerqueNew Mexico87106-
University at Buffalo MD Physicians GroupBuffaloNew York14203-
Asheville Clinical ResearchAshevilleNorth Carolina28803-
N.C. Children's Hospital - Children's Specialty Clinics - Chapel Hill at Carolina Pointe IIChapel HillNorth Carolina27514-
Sanford Medical Center FargoFargoNorth Dakota58104-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
UPMC Children's Hospital of PittsburghPittsburghPennsylvania15224-
Children's Medical Centre DallasDallasTexas75235-
Cook Children's Medical CenterFort WorthTexas76104-
Texas Children's Hospital - Clinical Care Center - Pediatric Renal ClinicHoustonTexas77030-
San Antonio Clinical TrialsSan AntonioTexas78240-
University of Virginia Health System - Pediatric Diabetes ClinicCharlottesvilleVirginia22903-
Benaroya Research Institute at Virginia MasonSeattleWashington98101-
Mary Bridge Children's Outpatient Center - TacomaTacomaWashington98405-3720-

Find similar trials in San Francisco, CA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of California San Francisco Benioff Children's Hospital· San Francisco, CASan Jose Clinical Trials, LLC· San Jose, CAUniversity of Colorado - Barbara Davis Center for Diabetes· Aurora, COUniversity of Florida College of Medicine· Gainesville, FLUniversity of Miami - Gables One Tower· Miami, FLChildren's Healthcare of Atlanta (CHOA) - Center for Advanced Pediatrics· Atlanta, GA

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