SCD0503 oral insulin clamp vs subcutaneous human insulin
Recruiting German Phase 1 euglycemic-clamp crossover of Sam Chun Dang’s oral regular human insulin (SCD0503, S-PASS platform) versus subcutaneous regular human insulin in men with Type 1 diabetes, including a food-effect arm. This is a bioavailability study, not a mealtime insulin pivotal.
Primary endpoints
- Serum insulin AUC and Cmax over 0–6 hours
- Glucose-infusion-rate AUC over 0–6 hours
Results so far
No results posted. Recruiting; estimated n=16; actual start 29 May 2026; estimated primary completion October 2026. Last registry update 9 June 2026. Dual-registered in CTIS as 2024-519502-12-00. First-patient dosing was reported by the sponsor in June 2026; that is not a PK table.
The full picture
SCD0503 is regular human insulin in an oral capsule, using Sam Chun Dang’s S-PASS absorption platform. Type 1 clamp volunteers are used because they make almost no of their own insulin, so the blood insulin you measure is the dose. That is a PK/PD convenience, not evidence that a tablet can replace mealtime injections.
The trial is small, male-only, and ends in estimated hours of clamp glucose infusion rate, not months of time in 70–180 mg/dL (3.9–10.0 mmol/L). No oral-insulin item is scored from this protocol. Oral insulin as antigen (prevention) is a different programme and is not this drug.