NCT07263152

QTc Assessment in a Single-Dose Study of Hydronidone Capsules

A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Effect of Single-Dose Hydronidone Capsules on QTc Interval in Chinese Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Beijing Continent Pharmaceutical Co, Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study was designed with three dose cohorts (A1-A3): a 90 mg cohort, a 270 mg cohort, and a 540 mg cohort. Each cohort enrolled 16 healthy Chinese participants, with 12 receiving the investigational product Hydronidone Capsules and 4 receiving placebo (i.e., matching placebo for Hydronidone Capsules). A total of 48 healthy Chinese subjects were planned for enrollment, and all participants received a single dose under fasting conditions.

Conditions

• Hepatic Fibrosis

Interventions

Type	Name	Description
DRUG	Hydronidone	Experimental group
DRUG	Placebo	Placebo group

Timeline

• Start date: 2025-12-31
• Primary completion: 2026-02-09
• Completion: 2026-02-09
• First posted: 2025-12-04
• Last updated: 2026-03-31

Locations

1 site across 1 country: China