drugset / Trial / NCT07162116

A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants

NCT07162116

Phase 1 Recruiting 45 enrolled Shijiazhuang Yiling Pharmaceutical Co. Ltd
RandomizedFactorialTriple-blindTreatment

Summary

This study plans to enroll 45 (Groups A, B, and C) to 75 healthy participants (including the sample size of other potential dose groups). The participants will be divided into three dose groups: 37.5 mg, 75 mg, and 150 mg. After taking the corresponding investigational product, participants are required to complete test procedures including QTc interval measurement , blood sampling, and vital sign monitoring. The entire test process lasts for 3 days. On the third day, after participants complete laboratory tests and are assessed by physicians as meeting the discharge criteria, they can be discharged.

Timeline

Start
2025-07-06
Primary completion
2025-12-01
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Comparator Moxifloxacin Small molecule 400 mg Oral
Subject XY0206 Unknown 37.5 mg Oral
Subject XY0206 Unknown 75 mg Oral
Subject XY0206 Unknown 150 mg Oral