Clinical Trial

QTc Assessment in a Single-Dose Study of Hydronidone Capsules

Completed Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-23.
Status change: Not Yet Recruiting → Completed 2026-03-25
Trial Details
NCT Number NCT07263152
Lead Sponsor Beijing Continent Pharmaceutical Co, Ltd.
Conditions Hepatic Fibrosis
Enrollment 48 participants
Start Date 2025-12-30
Primary Completion 2026-02-09 (estimated)
Study Completion 2026-02-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-13