This is a single-center, single-dose, open-label, positive-controlled, randomized, three-cycle, crossover 8-hour euglycemic clamp study to evaluate the PK, PD, safety and tolerability of THDB0206 injection after subcutaneous injection in healthy Chinese subjects. This trial will enroll 39 subjects to receive the investigational medicinal products.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall
0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall
0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall
West China Hospital of Sichuan University
Sichuan, China
AUCLisp(0-30 min)
Area under the insulin lispro plasma concentration-time curve from 0 to 30 minutes
Time frame: From 0 to 30 minutes
Cmax (Lisp)
The maximum plasma concentration of insulin lispro observed
Time frame: From 0 to 8 hours
AUCLisp
Area under the insulin lispro plasma concentration-time curve
Time frame: From 0 to 8 hours
tmax(Lisp)
Time to reach the maximum insulin lispro plasma concentration
Time frame: From 0 to 8 hours
t1/2
Terminal half-life
Time frame: From 0 to 8 hours
CL/F
Apparent clearance
Time frame: From 0 to 8 hours
Vz/F
Apparent volume of distribution
Time frame: From 0 to 8 hours
AUCGIR
Area under the glucose infusion rate-time curve
Time frame: From 0 to 8 hours
GIRtot
Total glucose infusion during clamping
Time frame: From 0 to 8 hours
GIRmax
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Maximum glucose infusion rate
Time frame: From 0 to 8 hours
tGIRmax
Time to reach the maximum glucose infusion rate
Time frame: From 0 to 8 hours
Number of participants with abnormal clinical laboratory findings (haematology, biochemistry and urinalysis)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal 12-lead ECG parameters (PR, QR, QRS intervals and QTc)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal vital signs (body temperature, supine blood pressure and pulse rate)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with abnormal physical examination (general condition, head and five sense organs, neck, chest, abdomen, spine and limbs, nervous system)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with hypoglycemia events in each treatment arm
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration)
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)
Number of participants with AE and SAE
Time frame: From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration)