Study of Azvudine Tablets to Assess Safety and How the Drug is Processed in Adults With Mild to Moderate Kidney Function Decline and Healthy Adults

What this Trial Is About

Researchers are studying the effects of Azvudine, a nucleoside reverse transcriptase inhibitor and broad-spectrum RNA virus inhibitor, on people with mild to moderate renal insufficiency and healthy individuals. This Phase 1 trial aims to understand how different levels of kidney function affect the drugs behavior in the body, its safety, and how well it is tolerated. The study is sponsored by Henan Genuine Biotech Co., Ltd. and involves adult participants aged 18 to 70 years old. Participants receive a single oral dose of 3 mg Azvudine tablets three tablets taken on an empty stomach on the first day of the study. The trial includes three groups those with mildly decreased kidney function, those with moderately decreased kidney function, and healthy volunteers matched by age, weight, and gender. The study uses an open-label, non-randomized, parallel design to monitor how the drug is processed in these groups. During the trial, blood and urine samples are collected up to 48 and 72 hours after dosing, respectively, to measure drug levels and other pharmacokinetic parameters. Safety exams and monitoring for any adverse effects occur from enrollment until day 4. Researchers evaluate outcomes such as maximum drug concentration, area under the concentration-time curve, and elimination half-life to understand the drugs behavior in participants with varying kidney function. The total study period includes screening, drug administration, and follow-up assessments.

A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects