NCT07262346

The Phase Ⅰd Clinical Trial of Hydronidone Capsules

Clinical Pharmacokinetic Study of Hydronione Capsules in Healthy Chinese Subjects (Ⅰd)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2025-12-05
• Primary completion: 2026-05-05
• Completion: 2026-05-05
• First posted: 2025-12-03
• Last updated: 2025-12-03

Locations

1 site across 1 country: China