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Phase 1RecruitingNCT07634770

SCD0503 oral insulin clamp vs subcutaneous human insulin

What this study tests

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.

Editorial review: .

Registry checked: 2026-09-17. Registry’s own update: 2026-06-09.

Most recent recorded citation date: 2026-06-09. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Men 18–64 with T1D for at least 12 months, BMI 18.5–29.9 kg/m², HbA1c 8.5% or lower, fasting C-peptide at most 0.20 nmol/L (0.6 ng/mL), total daily insulin below 1.2 U/kg, stable regimen for at least two months. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
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.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Serum insulin AUC and Cmax over 0–6 hours
  • Glucose-infusion-rate AUC over 0–6 hours

The full picture

The sponsor describes SCD0503 as regular human insulin in an oral tablet using its S-PASS delivery platform. The registry enrolls only people with T1D and fasting C-peptide at most 0.20 nmol/L, so measured blood insulin is largely the dose rather than endogenous secretion. That is a PK/PD convenience, not evidence that a tablet can replace mealtime injections.

The trial is small (registry-estimated n=16) and male-only, with registry primary outcomes over 0–6 hours (insulin AUC and Cmax, glucose-infusion-rate AUC and derived biopotency) — 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.

Sources

  1. [1]
  2. [2]