Clinical Trial

The Phase Ⅰd Clinical Trial of Hydronidone Capsules

Not Yet Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated December 3, 2025 (before its estimated May 5, 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07262346
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions Liver Fibrosis
Enrollment 138 participants
Start Date 2025-12-05
Primary Completion 2026-05-05 (estimated)
Study Completion 2026-05-05 (estimated)
Updated on ClinicalTrials.gov 2025-12-03