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QTc Assessment in a Single-Dose Study of Hydronidone Capsules

NCT07263152 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-31

No results posted yet for this study

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

DRUG

Hydronidone

Experimental group

DRUG

Placebo

Placebo group

Sponsors & Collaborators

  • Beijing Continent Pharmaceutical Co, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2026-02-09
Completion
2026-02-09

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07263152 on ClinicalTrials.gov