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A Study of SAB-142 to Slow the Progression of Type 1 Diabetes in Adults and Children Recently Diagnosed with the Disease

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Type 1 Diabetes, a condition where the body's immune system attacks and destroys the cells in the pancreas that make insulin, a hormone that helps control blood sugar levels. The study will test a treatment called SAB-142, which is a solution given through a vein, along with a placebo. SAB-142 contains human polyclonal immunoglobulin G against thymocyte, which is a type of antibody that may help protect the insulin-producing cells from being destroyed. Some participants will receive SAB-142 at different dose levels, while others will receive sodium chloride, which is a salt solution used as placebo.

The purpose of this study is to learn about the safety and tolerability of two different treatment plans in people who have recently been diagnosed with Stage 3 Type 1 Diabetes, and to find out whether the study treatment can help slow down the loss of insulin-producing cells in the pancreas over time. The study will also look at how well blood sugar levels are controlled, including information gathered from devices that continuously monitor glucose.

During the study, participants will receive the treatment through intravenous administration, which means the medicine will be given directly into a vein. The treatment period will last for several months, and participants will be monitored regularly for any side effects or health problems that may occur. Doctors will also check how well the pancreas is working and measure insulin production throughout the study. The study is designed to compare different dose levels of SAB-142 with placebo to determine which approach works best and is safest for people with newly diagnosed Type 1 Diabetes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment and preparation

    Upon joining the study, you will be randomly assigned to one of three groups. This process is called randomisation and ensures that the assignment is done by chance, similar to flipping a coin.

    One group will receive a low dose of SAB-142, another group will receive a high dose of SAB-142, and the third group will receive a placebo. A placebo is an inactive substance that looks like the real treatment but contains no active medicine.

    Neither you nor your doctor will know which treatment you are receiving during the study. This is called a double-blind design and helps ensure accurate results.

  2. Step 2

    Receiving the study treatment

    You will receive the assigned treatment through an intravenous infusion. This means the medicine will be given directly into your vein through a small tube inserted into your arm.

    The treatment product is SAB-142, which contains human polyclonal immunoglobulin g against thymocyte, or sodium chloride solution if you are in the placebo group.

    The solution will be administered as an infusion, which means it will drip slowly into your vein over a period of time.

    The specific dose you receive will depend on which treatment group you are assigned to. The study is designed to compare two different dose levels of SAB-142 against placebo to determine which works best.

  3. Step 3

    Monitoring for side effects and health problems

    Throughout the study, any health problems or side effects you experience will be recorded and reviewed by the study team.

    This monitoring is important to understand the safety and tolerability of the treatment, which means how well your body handles the medicine and whether it causes any unwanted effects.

  4. Step 4

    Assessment of pancreas function

    Your pancreas function will be checked regularly during the study. The pancreas is the organ that produces insulin, a hormone that helps control blood sugar levels.

    These checks will measure how well your pancreas is producing insulin. The purpose is to see whether the treatment can help slow the decline of insulin-producing cells in your pancreas.

    This is one of the main goals of the study, as preserving these cells may help manage type 1 diabetes better over time.

  5. Step 5

    Blood sugar monitoring

    Your blood sugar control will be monitored throughout the study. This includes regular measurements to see how well your blood sugar levels are being managed.

    You may be asked to use a continuous glucose monitoring device. This is a small device that tracks your blood sugar levels throughout the day and night without needing frequent finger pricks.

    The information from this monitoring will help assess how the treatment affects your diabetes management.

  6. Step 6

    Study duration and follow-up

    The study is expected to continue until March 2029. During this time, you will have regular visits and assessments as scheduled by the study protocol.

    Throughout the study period, you must not participate in other experimental treatments or clinical trials.

    The extended duration allows for proper evaluation of how the treatment affects the progression of type 1 diabetes over time.

Who can join the trial?

5 criteria

  • You must be up to 40 years old and recently diagnosed with Stage 3 type 1 diabetes, which means your body has started showing clear signs that it cannot properly control blood sugar levels
  • You must be up to date with all vaccines that are required by your local or national health authorities
  • If you are female, you must meet conditions that prevent pregnancy during the study, for example: you have not yet started your menstrual periods, you have gone through menopause which means your monthly periods have stopped permanently, you have had certain surgeries that prevent pregnancy, or you are using reliable birth control methods to prevent pregnancy
  • You must have a positive test result for at least one antibody linked to type 1 diabetes, which are proteins in your blood that indicate your immune system is attacking the cells that make insulin in your pancreas
  • You must agree not to take part in other experimental treatments during the study

Who cannot join the trial?

5 criteria

  • The study information does not list specific reasons why patients cannot participate in this clinical trial
  • If you have been recently diagnosed with Type 1 Diabetes, which is a condition where the body cannot produce enough insulin (a substance that helps control blood sugar levels), you may want to discuss with your doctor whether this study could be suitable for you
  • The study is looking at the safety of treatments and whether they can help protect the cells in the pancreas (an organ in your body) that make insulin
  • The study accepts both male and female participants
  • The study includes adults and children as participants
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Investigated drugs

  • SAB-142

    is an investigational medication being studied to see if it can help slow down the progression of type 1 diabetes in people who have recently been diagnosed. The study is testing whether this treatment can help protect the cells in the pancreas that produce insulin, which are damaged in type 1 diabetes. Researchers want to learn if SAB-142 is safe and well-tolerated, and if it can delay the worsening of the disease.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare the effects of SAB-142 against no active treatment, which helps researchers determine if the medication is truly effective.

What is already known about the treatment

SAB-142 – SAB-142 is an experimental medication currently being tested in clinical trials for patients who have been recently diagnosed with Type 1 Diabetes. This drug is being studied to determine if it can help slow down the loss of the body's ability to produce insulin by protecting the insulin-making cells in the pancreas. The medication is being evaluated in a Phase 2b trial to find the right dose and to assess how safe it is for patients with new-onset Type 1 Diabetes. The exact way SAB-142 works at the cellular level is being investigated, but it is designed to interfere with the immune system's attack on insulin-producing cells, potentially preserving the pancreas's natural function for a longer period.

Investigated diseases

Type 1 Diabetes – Type 1 diabetes is a condition where the body's immune system attacks and destroys the insulin-producing cells in the pancreas. Without enough insulin, the body cannot properly control blood sugar levels, causing glucose to build up in the bloodstream. This disease typically develops quickly over weeks or months, often appearing in childhood or young adulthood, though it can occur at any age. As the condition progresses, the pancreas produces less and less insulin until very little or none remains. People with this condition experience symptoms such as increased thirst, frequent urination, extreme hunger, weight loss, and fatigue. The disease requires lifelong management to maintain healthy blood sugar levels and prevent complications affecting various organs and body systems.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521560-36-00Protocol codeSAB-142-201Estimated enrolment190 patientsSponsorSab Biotherapeutics Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).