Type 1 Diabetes happens when the immune system attacks the cells that make insulin. Once these cells are gone, the body cannot make insulin, and blood sugar is hard to control. This can lead to serious health problems over time. This study wants to find out if a new experimental drug called SAB-142 works to help protect these cells, so the body can continue to make insulin. This could make blood sugar easier to manage and lower the risk of complications. SAB-142 is considered experimental because it has not yet been approved by the United States Food and Drug Administration (FDA) for the treatment of diabetes. This study will have about 159 participants including adults, adolescents, and children from several locations around the world. If you join, you will first have a pre-screening and screening visit. At these visits, the study team will check your health and make sure you can join. You will have blood tests, a physical exam, an ECG to check your heart, urine tests, and a mixed-meal tolerance test where blood samples will be taken before and after drinking a protein shake. You will be asked to wear a continuous glucose monitor (CGM) for several short periods during the study. The study has two parts. Which part you join depends on when you start. In Part A, up to 12 people will get SAB-142 at one of two dose levels. In Part B, up to 147 people will be randomly assigned to a group, like flipping a coin, and get either a high dose of SAB-142, a low dose, or a placebo. A placebo looks like a drug but has no active medicine. Part A is open label, so you and the study doctor will know what group you are assigned. Part B is double-blind, so neither you nor the study doctor will know what group you are assigned to. After the screening visit, you will begin the Treatment Period. There are two treatment periods throughout the study. You will get the study drug or placebo through a small needle in your arm called an IV Infusion over two consecutive days. You will repeat this infusion for each treatment period. The infusion lasts about 6 hours on Day 1, and about 4-6 hours on Day 2. After the treatment period, you will continue with follow-up visits. These visits include blood test, CGM placement, and questionnaires. You will have 13-14 in-person visits and 3 phone calls in total. The whole study will last up to around 15 months from the time of screening until the end of the study. You will be paid $300 for each treatment visit, $25 for each phone call, $50 for the optional screening visit, and $100 for all other visits. If you complete all visits, you can earn up to $2, 225. If you leave the study early, you will be paid for the visits you complete.

Who can Participate

You may be able to join the study if you are between 5 and 40 years old and diagnosed with Type 1 Diabetes within the last 100 days. You must test positive for certain diabetes related antibodies. You must be in good health and free of infections such as HIV and hepatitis. Both men and women must use reliable birth control methods while in the study.

Study ID