NCT05328843

Study to Evaluate the Pharmacokinetic Characteristics of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function

An Open-label Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics of Single-dose of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a single-dose, parallel grouping, open-label phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of PB-119 in subjects with different degrees of renal insufficiency and matched subjects with normal renal function.

Detailed description

This study plans to enroll 24 subjects, which are divided into three groups: Group A: subjects with mild renal insufficiency (chronic kidney disease \[CKD\] stage 2); Group B: subjects with moderate renal insufficiency (CKD3 stage 3); Group C: subjects with normal renal function. The estimated glomerular filtration rate (eGFR, mL/min/1.73m2) transformed according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula should be converted into individual glomerular filtration rate (GFR, mL/min) as an indicator of CKD grading, and subjects should be stratified according to different degrees of renal function.

Conditions

• Type2Diabetes

Interventions

Type	Name	Description
DRUG	PB119	Each subject received only one dose of study drug during the study period. After completing the pre-dose procedure on the morning of the first day of the study, the subjects were given a subcutaneous injection of PB-119 0.3 mL (150 μg) once in the abdomen by the study nurse. The actual time of administration will be recorded in the subject's eCRF. Subjects should remain on an empty stomach for at least 10 hours prior to administration.

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-10-01
• Completion: 2022-10-01
• First posted: 2022-04-14
• Last updated: 2022-04-14

Locations

1 site across 1 country: China