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Phase I Study of Single-Dose Zovaglutide Injection Evaluating Safety and Pharmacokinetics in Adults With Various Levels of Kidney Function and Healthy Adults
Led by Beijing QL Biopharmaceutical Co.,Ltd · Updated on 2026-04-20
40
Participants Needed
3
Research Sites
15 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the pharmacokinetic PK characteristics and safety of a single subcutaneous injection of Zovaglutide ZT002 Injection in adults with different levels of kidney function, including those with normal renal function and varying degrees of renal insufficiency. This phase I, open-label study aims to understand how the drug behaves in the body and its safety profile across these groups. Participants are assigned to one of four groups based on kidney function mild, moderate, severe renal impairment, or healthy controls. Each participant receives a single dose of Zovaglutide by subcutaneous injection. The study monitors how the drug is processed in the body over time, with follow-up lasting up to 50 days after treatment. During the study, participants will undergo regular assessments including blood sampling to measure drug concentration and kidney function, and monitoring for any adverse events. The primary outcomes include measurements such as the drugs concentration over time, maximum concentration, half-life, clearance, and time to maximum concentration. Safety is closely observed from screening through day 50, ensuring comprehensive monitoring during the study period.
CONDITIONS
Brief Title
A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants
Research Team
Y
Yujie Deng, PhD
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