Safety and Pharmacokinetics Study of Single-Dose Hydronidone Capsules in Adults With and Without Renal Insufficiency

What this Trial Is About

Researchers are studying Hydronidone capsules, a new pyridinone-based drug, to understand its safety and how it behaves in the body, especially in patients with kidney problems. Although preliminary studies showed Hydronidone may be safe and effective for liver fibrosis caused by chronic hepatitis B, this trial focuses on how the drug works and is tolerated in people with different levels of kidney function. Participants will take a single 90mg dose of Hydronidone capsules on an empty stomach on the first day. The study includes groups of healthy individuals and patients with mild, moderate, or severe renal insufficiency, defined by their estimated glomerular filtration rate eGFR. Each participant receives the same dose, and the trial compares these groups to assess differences in drug processing. During the study, researchers will collect blood and urine samples over 48 hours to measure drug and metabolite levels. Safety will be monitored through ultrasound exams of various organs and electrocardiograms within 72 hours after dosing. Participants will be observed for any adverse events, and their overall health will be assessed before and after the study period, which runs until July 2026.

A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients With Renal Insufficiency