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

NCT05328843 · Unknown status

Last updated 2026-05-28

This clinical trial is testing how a diabetes medication called pegylated exenatide (PB-119) moves through the body in people with varying levels of kidney function compared to those with normal kidney function.

Status Unknown status The sponsor has not confirmed the status recently.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 24 people Planned (estimated).

Who can join Ages 18–75 · all sexes Healthy volunteers accepted.

Timeline Started 2022-05 · est. completion 2022-10

Where 1 site · China

What this study is testing ClinicalTrials.gov NCT05328843 ↗

Description as written by the study sponsor.

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.

Treatments tested

PB119 Drug

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.

Main thing measured	Primary PK parameters: AUC0-inf
Sponsor	PegBio Co., Ltd.
Conditions studied	Type2Diabetes
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05328843 ↗