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

Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase. This trial uses a non-randomized, open-label, parallel, single-dose adaptive design aimed at investigating the effects of varying degrees of renal insufficiency on the pharmacokinetics, safety, and tolerability of a single oral dose of 3 mg Azvudine tablets in humans. On the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach. Biological sample collection and safety examination will be performed in this trial.

NCT Number	NCT07001436
Lead Sponsor	Henan Genuine Biotech Co., Ltd.
Conditions	Renal Insufficiency
Enrollment	40 participants
Start Date	2025-05-20
Primary Completion	2025-08-30 (estimated)
Study Completion	2025-09-30 (estimated)
Updated on ClinicalTrials.gov	2025-06-03