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.
The study evaluates the safety, tolerability, and PK profile of DM199 in subjects with T1D or T2D and with Stage 3 or Stage 4 CKD. Additionally, this study evaluates urine concentrations of KLK1 pre and post dose. Cohort 1: Subjects with T1D or T2D and Stage 3 CKD will be administered one of three DM199 doses: 3.0 ug/kg or 5.0 ug/kg or 8.0 ug/kg single SC dose. Cohort 2: Subjects with T1D or T2D and Stage 4 CKD will be administered a single 3.0 µg/kg single SC dose. Secondary and exploratory study objectives include collection and analysis of vital signs, biomarkers, eGFR, blood glucose, and ECG's.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Single SC dose
Clinical Pharmacology of Miami
Hialeah, Florida, United States
Orlando Clinical Research Center Inc
Orlando, Florida, United States
Prism Research
Saint Paul, Minnesota, United States
Safety as assessed by incidence, severity, and causality of adverse events
Time frame: 11 days
Tolerability as assessed by incidence and severity of AEs
Time frame: 11 days
plasma measurements of DM199
as measured in the three different dosing groups; 3.0 ug/kg, 5.0 ug/kg, and 8.0 ug/kg.
Time frame: 11 days
DM199 urine concentrations of KLK1
urine KLK1 will be measured pre and post study drug administration.
Time frame: 11 days
C Reactive protein (CRP)
Time frame: 11 days
Matrix Metalloproteinase-9 (MMP-9)
Time frame: 11 days
Vascular Endothelial Growth Factor (VEGF)
Time frame: 11 days
Nitric Oxide (NO)
Time frame: 11 days
Serum creatinine
Time frame: 11 days
Cystatin C
Time frame: 11 days
neutrophil gelatinase-associated prostaglandin E2
Time frame: 11 days
Urine Kidney Injury Molecule-1 (Kim1)
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Time frame: 11 days