Methods
TYPE 1 DIABETES
We performed an FIH Phase 1b/2a study with AG019 and teplizumab in participants with recent-onset type 1 diabetes, recruited from 15 clinical sites in the USA and Belgium. The study protocol and its amendments, and the informed consent forms, were approved by an independent ethics committee and institutional review board. All participants/parents/guardians provided written informed consent before study entry. A data safety monitoring board reviewed the safety data at prespecified timepoints.