QTc Assessment in a Single-Dose Study of Hydronidone Capsules (NCT07263152) | Clinical Trial Compass
CompletedPhase 1
QTc Assessment in a Single-Dose Study of Hydronidone Capsules
China48 participantsStarted 2025-12-31
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* 1\) Participants who were fully informed about this trial before the experiment, understood the content, process and possible adverse events related to the experimental drug, and voluntarily signed the written informed consent form.
* 2\) Male or female participants aged 18 to 50 years (including the upper and lower limits) at the time of signing the informed consent form.
* 3\) Male participants with a weight of ≥50.0 kg and female participants with a weight of ≥45.0 kg at the time of screening, and a body mass index (BMI) of 19.0 to 26.0 kg/m2, including the boundary values.
* 4\) Participants whose medical history inquiries, laboratory tests and related examinations (vital signs, physical examination, 12-lead ECG, chest X-ray, abdominal color Doppler ultrasound, etc.) were all normal or whose abnormalities were judged by the researcher to have no clinical significance at the time of screening.
Exclusion Criteria:
* 1\) The researcher determines that there are other diseases or medical histories that have clinical significance or may prevent participants from following the research protocol and completing the study, including but not limited to abnormalities in the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, immune system, nervous system, endocrine and metabolic system, etc.
* 2\) There is a history of cardiovascular system diseases or risk factors for torsade de pointes (TdP) su…
What they're measuring
1
The relationship between plasma drug concentration and placebo-corrected change from baseline in QTc interval (ΔΔQTc) following single-dose administration of Hydroxynidone Capsules