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The Phase Ⅰd Clinical Trial of Hydronidone Capsules

NCT07262346 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-12-03

No results posted yet for this study

Summary

Based on the Phase I (Ia, Ib, Ic) clinical pharmacokinetic study of Hydronidone Capsules, a clinical pharmacokinetic trial of Hydronidone Capsules (specification: 30 mg/capsule) was conducted, including single-dose administration, multiple-dose administration, and a food-effect study. The aim was to investigate the safety, tolerability, and pharmacokinetic characteristics of higher doses of Hydronidone Capsules (specification: 30 mg/capsule) in healthy subjects, in preparation for future expansion of indications.

Conditions

  • Liver Fibrosis

Interventions

DRUG

Hydronidone capsules

SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs

DRUG

Placebo capsules

SAD:Single-dose administration MAD:Multiple-dose group Study on the Interaction between Food and Drugs

Sponsors & Collaborators

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

    collaborator OTHER

  • Beijing Continent Pharmaceutical Co, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2026-05-05
Completion
2026-05-05

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 NCT07262346 on ClinicalTrials.gov