Study of Pharmacokinetics and Safety of GZR18 Injection in Subjects With Renal Impairment and Normal Renal Function
Trial Parameters
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Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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. 2.Subjects (male or female) age ≥ 18 and ≤ 75 years at the time of signing ICF. 3.Subjects with childbearing potential from signing the ICF to 8 weeks after the last dose have no family planning, are willing to adopt effective contraceptive measures and have no plans for sperm donation; women of childbearing potential are not pregnant or lactating: they must have a negative pregnancy test at screening and have no unprotected sexual intercourse within 2 weeks before screening. 4.Subjects weighing ≥ 50 kg and 20 ≤ BMI ≤ 40 kg/m2 at screening. 5.Subjects with normal renal function must also meet the following conditions: 1. 90 mL/min ≤ individual's GFR \< 130 mL/min at screening (see Appendix 2: Formulas Involved in the Protocol for