drugset / Trial / NCT03795389
Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
Non-randomizedParallel-groupOpen-labelTreatment
Summary
An open-label, phase IB, multi-center study evaluating DM199 in subjects with Type 1 Diabetes or Type 2 Diabetes and Stage 3 or 4 Chronic Kidney Disease. The primary objectives of this study are to evaluate safety, tolerability, and PK profile of DM199 in these subjects.
Timeline
- Start
- 2019-02-12
- Primary completion
- 2019-07-21
- Completion
- 2019-07-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rinvecalinase Alfa | Protein / enzyme biologic | 3 ug/kg | Subcutaneous |
| Subject | Rinvecalinase Alfa | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Subject | Rinvecalinase Alfa | Protein / enzyme biologic | 8 ug/kg | Subcutaneous |