NCT07634770
Bioavailability, Biopotency and Food Effect Study of SCD0503 Compared to Subcutaneous Regular Human Insulin
Recruiting · Phase 1 · Sam Chun Dang Pharm. Co. Ltd. · registry updated 2026-06-09
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
Reason for the study The participants have been diagnosed with type 1 diabetes and are being treated with standard insulin therapy. The sponsor of the study is developing a new insulin-based medicine that can be taken by mouth (orally). For this reason, the investigational product named SCD0503 is to be tested in the study. The sponsor wants to investigate the course of blood concentrations and the blood sugar-lowering effect of the investigational product and to find out whether SCD0503 is safe. Investigational product tested in this study The investigational product tested, SCD0503, is still under clinical evaluation and has not yet been approved for your treatment. The active ingredient is regular human insulin, which has been used for many years in approved medicines for the treatment of diabetes. SCD0503 is being used in humans for the first time in this study. Study procedures The study will last for approximately 1 to 4 months. During this time, the participant will come to the investigational site 8 times for visits. During 4 visits the participant will undergo a clamp examination....
Inclusion
- Male person with type 1 diabetes mellitus
- Age between 18 and 64 years, both inclusive
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m2, both inclusive
- HbA1c ≤ 8.5%
- Fasting C-peptide \<= 0.20 nmol/L
- Total insulin dose of \<1.2 (I)U/kg/day
Exclusion
- Systolic blood pressure \< 90 mmHg or \>139 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 89 mmHg
- Heart rate at rest outside the range of 50- 90 beats per minute
- Clinically significant abnormal standard 12-lead electrocardiogram (ECG) after 5 minutes resting in supine position at screening
- Proliferative retinopathy or maculopathy as judged by the investigator based on a recent (\<1 year) ophthalmologic examination
- Peripheral neuropathy
- More than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months pior to screening