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

NCT07262333 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2026-08-13

No results posted yet for this study

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.

Conditions

  • Renal Insufficiency Chronic

Interventions

DRUG

Hydronidone capsules

Take 90mg orally on an empty stomach on Day 1.

Sponsors & Collaborators

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    collaborator OTHER

  • Beijing Continent Pharmaceutical Co, Ltd.

    lead INDUSTRY

Principal Investigators

  • shaojun Shi · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-25
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07262333 on ClinicalTrials.gov