Overview

QTc Assessment in a Single-Dose Study of Hydronidone Capsules

Status:
NOT_YET_RECRUITING
Trial end date:
2026-01-30
Target enrollment:
Participant gender:
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.
Phase:
PHASE1
Details
Lead Sponsor:
Beijing Continent Pharmaceutical Co, Ltd.
Treatments:
hydronidone