This study adopts a multicenter, single-dose, open-label, and parallel design, which is aimed at assessing the PK and safety profiles of GZR18 Injection in subjects with normal renal function and those with mild, moderate or severe renal impairment.
The study duration for each subject in this study is up to 50 days, including a screening period of up to 14 days (Day-14 to Day-1), an 8-day dosing/observation period (Day 1 to Day 8), and a 28-day follow-up period (Day 9 to Day 36).
1.Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
90 mL/min ≤ individual's GFR < 130 mL/min at screening (see Appendix 2: Formulas Involved in the Protocol for the calculation formula).
Subjects with normal laboratory test results, vital signs, ECG, physical examination, chest AP view, abdominal B-ultrasound, and other examination results at screening or without clinically significant abnormalities as assessed by the investigator.
Mild renal impairment group: 60 mL/min ≤ individual's GFR < 90 mL/min at screening; moderate renal impairment group: 30 mL/min ≤ individual's GFR < 60 mL/min at screening; severe renal impairment group: 15 mL/min ≤ individual's GFR < 30 mL/min at screening.
1.Subjects with allergic constitution, including those with a history of severe drug allergy or hypersensitivity reactions, and those known or suspected to be allergic to GLP-1 drugs or their excipients as considered by the investigator.
Single group
GZR18 injection
DrugGZR18 injection:3mg
Cmax:Maximum plasma concentration
AUC0-last:Area under the plasma concentration-time curve at 0 h to last observation time-point after a single dose.
AUC0-inf:Area under the plasma concentration-time curve at 0 h to infinity after a single dose.
AUC0-336 h：Area under the plasma concentration-time curve from time zero to 336 hours
Tmax:Time of Maximum Drug ConcentrationTime to Maximum aentration
TEAE：Treatment Emergent Adverse Event
Click on the lead sponsor to view all of their trials.
