Pharmacokinetics of Benaglutide Injection in Overweight/Obese Adults
Status:
Completed
Trial end date:
2021-05-20
Target enrollment:
Participant gender:
Summary
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.