RecruitingPhase 1NCT07262333

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

Safety and Pharmacokinetics of Single-dose Hydroxynidone Capsules in Patients With Renal Insufficiency

Sponsor

Beijing Continent Pharmaceutical Co, Ltd.

Enrollment

56 participants

Start Date

Dec 25, 2025

Study Type

INTERVENTIONAL

Conditions

Renal Insufficiency, Chronic

Summary

Hydronidone capsules are pyridinone-based small molecule compounds. Hydronidone has not been approved for commercial sale both domestically and internationally. The applicant has completed the preliminary Phase I and Phase II clinical trials. The results showed that Hydronidone is a safe and effective drug for treating liver fibrosis in chronic hepatitis B, and it has good safety and tolerability. Based on the preliminary clinical research, a special population study has been initiated. The aim is to investigate the pharmacokinetic differences and safety of honginone capsules in patients with renal insufficiency and healthy subjects, in order to provide a basis for the clinical medication of patients with renal dysfunction.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing how the body processes a new drug called hydroxynidone in people with various levels of kidney function — from healthy individuals to those with mild, moderate, or severe kidney disease — to determine if dose adjustments are needed. **You may be eligible if...** - You are a healthy adult with normal kidney function (eGFR ≥90), OR - You have been diagnosed with mild, moderate, or severe kidney dysfunction at specific eGFR thresholds - You meet general health requirements for the study **You may NOT be eligible if...** - You are on dialysis or have end-stage kidney disease requiring dialysis - You have significant liver, heart, or other conditions that would affect how the drug is processed - You have taken medications that could interfere with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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