A Phase I Clinical Study to Evaluate the Pharmacokinetic Characteristics and Safety of Single-dose of Zovaglutide (ZT002 Injection) in Participants With Different Degrees of Renal Insufficiency and Matched Participants With Normal Renal Function
This study is a single-dose, open-label, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with different degrees of renal insufficiency and matched participants with normal renal function.
• Ability to understand the trial procedures and possible adverse events, be able and willing to provide a written informed consent;
• Male or female, age between 18 - 75 years (both inclusive) at the time of signing of the informed consent.
• Body mass index (BMI) 19.0 - 32.0 kg/m²(both inclusive). Body weight ≥50 kg for male participants and ≥45 kg for female participants.
• Diagnosed as stable, chronic renal disease for at least 3 months.
• Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
• Normal renal function: 90-129 mL/min (inclusive); Mild impairment: 60-89 mL/min (inclusive); Moderate impairment: 30-59 mL/min (inclusive); Severe impairment: 15-29 mL/min (inclusive);
• Stable renal function, assessed by two eGFR during screening.