RecruitingPhase 1NCT07162116

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

A Single-center, Randomized, Double-blind, Placebo- and Positive Drug (Open-label Design) Controlled Phase I Clinical Study to Evaluate the Effect of a Single Oral Dose of XY0206 Tablets on QTc Interval in Healthy Chinese Participants.

Sponsor

Shijiazhuang Yiling Pharmaceutical Co. Ltd

Enrollment

45 participants

Start Date

Jul 6, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia With FLT3/ITD Mutation

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.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called XY0206 in healthy Chinese volunteers to see whether it affects the heart's electrical rhythm (specifically the QT interval on an ECG). This type of study is a standard safety check done before a drug moves forward in development. **You may be eligible if...** - You are a healthy adult aged 18 to 45 - Men must weigh at least 50 kg, women at least 45 kg - Your BMI is between 19.0 and 26.0 - All standard health checks (blood tests, ECG, chest X-ray, ultrasound) come back normal or with only minor, clinically insignificant findings - You can communicate well with the research team and follow study procedures **You may NOT be eligible if...** - You have any current significant health conditions - You have abnormal ECG results or a history of heart rhythm problems - You are taking medications that affect heart rhythm - You are pregnant, breastfeeding, or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXY0206

12.5 mg/table,On the morning of the day of dosing , subjects received XY0206 tablets orally on an empty stomach.Each group of 15 subjects was randomly assigned in a 3:1:1 ratio, with 9 receiving XY0206, 3 receiving a placebo of XY0206, and 3 receiving moxifloxacin.Group A (XY0206 tablets: 37.5 mg; moxifloxacin : 400 mg; placebo: 37.5 mg)；Group B(XY0206 tablets: 75 mg; moxifloxacin : 400 mg; placebo: 150mg)；Group C(XY0206 tablets:150 mg; moxifloxacin : 400 mg; placebo: 150mg)

DRUGMoxifloxacin (400 mg)

400mg，On the morning of the day of dosing , subjects received moxifloxacin orally on an empty stomach

OTHERXY0206 Placebo

12.5mg/table,On the morning of the day of dosing, subjects received XY0206 placebo orally on an empty stomach.Each group of 15 subjects was randomly assigned in a 3:1:1 ratio, with 9 receiving XY0206, 3 receiving a placebo of XY0206, and 3 receiving moxifloxacin.Group A (XY0206 tablets: 37.5 mg; moxifloxacin : 400 mg; placebo: 37.5 mg)；Group B(XY0206 tablets: 75 mg; moxifloxacin : 400 mg; placebo: 150mg)；Group C(XY0206 tablets:150 mg; moxifloxacin : 400 mg; placebo: 150mg)

Locations(1)

PKUCare Luzhong Hospital

Zibo, Shandong, China

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NCT07162116

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