QTc Assessment in a Single-Dose Study of Hydronidone Capsules

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.

Timeline

Start

2025-12-31

Primary completion

2026-02-09

Completion

2026-02-09

Drugs

Indications