This study is a open and multiple dose escalation phase I clinical study, aiming to evaluate the pharmacokinetic characteristics and safety of Benaglutide Injection in overweight/obese adults after multiple subcutaneous injections. This study will enroll 16 overweight/obese adults, both male and female. The trial was divided into two batches, including 4 subjects who completed all dosing, safety assessment and telephone follow-up, and the remaining 12 subjects who were enrolled for the trial. All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing. The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days. Subjects will be screened at D-14-D-2, and eligible subjects D-2 will be admitted to the phase I clinical trial ward at D-2. D-1 Blank blood samples were collected at different time points before and after breakfast for PK test baseline correction. D1 began by subcutaneously injecting different doses of benaglutide injection 5 minutes before the daily three meals, collecting biological samples at different time points after the first administration of D6, D7, D11, D12 and D16 to evaluate the pharmacokinetic characteristics of Benaglutide. Subjects will be discharged after all samples are collected and safety assessed at D17. Telephone follow-up was performed on the 7th day after discharge (D24±2) to further observe safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
All subjects received multiple doses (tid) of 0.06 mg, 0.1 mg, 0.14 mg, and 0.2 mg in sequence, followed by the next dose after completing the previous multiple dosing. The administration time of each dose was 0.06 mg for 3 days, 0.1 mg for 3 days, 0.14 mg for 5 days, and 0.2 mg for 5 days.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Peak Plasma Concentration (Cmax)
Evaluation of Peak Plasma Concentration (Cmax)
Time frame: 80 days
Area under the plasma concentration versus time curve (AUC)0-t
Evaluation of Area under the plasma concentration versus time curve (AUC)0-t
Time frame: 80 days
Area under the plasma concentration versus time curve (AUC)0-∞
Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Time frame: 80 days
elimination half-life time(T1/2)
Evaluation of elimination half-life time(T1/2)
Time frame: 80 days
The total clearance(CL)
Evaluation of the total clearance(CL)
Time frame: 80 days
Incidence of Treatment Adverse Events
Collection of adverse events
Time frame: 80 days
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