Phase 2 Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes

Phase 2, randomised, double-blind trial of PS1 in type 1 diabetes mellitus (T1D) (5 arms), sponsored by Pharmasaga Co. Ltd. Primary endpoints: Change from Baseline in 4-Hour Mixed-Meal Tolerance Test (MMTT)-Stimulated C-Peptide Area Under the Curve (AUC) at 4 months and Pharmacokinetics (PK) of PS1 at Day 8. Planned start Nov 2026; status: not yet recruiting.