This study investigated the safety, efficiency, pharmacokinetics and pharmacokinetics of CARC-101C in patients with autoimmune type 1 diabetes. A single dose, dose escalation, open study design was used.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
12
Subjects enrolled in the project will received a one-dose injection of CARC-101C
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, China
Incidence and severity of adverse events within 3 weeks after administration (NCI CTCAE V5.0).
Time frame: 21 days
Changes of AUC(Area Under Curve) compared with baseline fasting and MMTT-stimulated C-peptide at 4, 12, 24, 36, 52 and 76 weeks.
Time frame: 4, 12, 24, 36, 52 and 76 weeks
Changes of C-peptide compared with baseline in fasting and 2h after MMTT(Mixed-meal tolerance test)-stimulated at 4, 12, 24, 36, 52 and 76 weeks.
Time frame: 4, 12, 24, 36, 52 and 76 weeks
Percentage of subjects with HbA1c < 7% at 12, 24, 36, 52 and 76 weeks.
Time frame: 12, 24, 36, 52 and 76 weeks
Diachronic change of HbA1c from baseline at 12, 24, 36, 52 and 76 weeks.
Time frame: 12, 24, 36, 52 and 76 weeks
Percentage of subjects whose weekly mean insulin requirement decreased by 50% or more at 4, 12, 24, 36, 52 and 76 weeks.
Time frame: 4, 12, 24, 36, 52 and 76 weeks
Diachronic change in weekly mean insulin requirement from baseline at 4, 12, 24, 36, 52 and 76 weeks.
Time frame: 4, 12, 24, 36, 52 and 76 weeks
Homeostatic model assessment of β-cell function (HOMA-β) from baseline at 4, 12, 24, 36, 52 and 76 weeks.
Time frame: 4, 12, 24, 36, 52 and 76 weeks
Time in Range (TIR, time of glucose readings at 3.9 to 10.0 mmol/L) changes from baseline in indicators associated with continuous glucose monitoring at 12, 24, 36, 52 and 76 weeks.
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Time frame: 12, 24, 36, 52 and 76 weeks
Percentage of subjects with TIR >70% from baseline by continuous glucose monitors compared with baseline at 12, 24, 36, 52 and 76 weeks;
Time frame: 12, 24, 36, 52 and 76 weeks
Maximum concentration observed (Cmax) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;
Time frame: Day1,Day2,Day5,Day7,Day21,Week4,Week12
Time at which the maximum concentration (Tmax ) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;
Time frame: Day1,Day2,Day5,Day7,Day21,Week4,Week12
AUC up to the last measurable concentratio(AUC (0-t)): of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;
Time frame: Day1,Day2,Day5,Day7,Day21,Week4,Week12
AUC curve to infinite time(AUC (0--∞)) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;
Time frame: Day1,Day2,Day5,Day7,Day21,Week4,Week12
Terminal phase rate constant(λz) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;
Time frame: Day1,Day2,Day5,Day7,Day21,Week4,Week12
Terminal phase half-life (t1/2) of CARC-101C at Day1,Day2,Day5,Day7,Day21,Week4,Week12;
Time frame: Day1,Day2,Day5,Day7,Day21,Week4,Week12
Changes of the T cell subpopulation compared with baseline at 3, 4, 12, 24, 36, 52 and 76 weeks;
Time frame: 3, 4, 12, 24, 36, 52 and 76 weeks
Changes of the presence of pathogenicity related T cells compared with baseline at 3, 4, 12, 24, 36, 52 and 76 weeks;
Time frame: 3, 4, 12, 24, 36, 52 and 76 weeks
Incidence and severity of adverse events within 76 weeks after administration according to version 5.0 of NCI CTCAE.
Time frame: 76 weeks
Changes of Insulin Autoimmune Antibodies(IAA)compared with baseline at 4, 12, 24, 36, 52 and 76 weeks;
Time frame: 4, 12, 24, 36, 52 and 76 weeks
Changes in cytokine levels.
Time frame: 76 weeks