Actively Recruiting
A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants
Led by Shijiazhuang Yiling Pharmaceutical Co. Ltd · Updated on 2025-09-09
45
Participants Needed
1
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants voluntarily sign a written informed consent form.
- Male or female; aged between 18 and 45 years old (inclusive).
- Male participants weigh 65 50kg, female participants weigh 65 45kg, and their body mass index (BMI) is between 19.0 and 26.0 kg/m, inclusive.
- Physical examination, laboratory tests, and all trial-related examinations at screening are normal or have only minor abnormalities without clinical significance.
- Participants can communicate well with the researchers and comply with the protocol requirements to complete the study.
You will not qualify if you...
- History of severe systemic diseases, mental disorders, or drug dependence.
- History of drug or food allergies, or allergy to XY0206, moxifloxacin, fluoroquinolones, or FLT3 inhibitors.
- History of swallowing difficulties or gastrointestinal diseases affecting drug absorption.
- Hemorrhoids or perianal diseases with regular bleeding, irritable bowel syndrome, inflammatory bowel disease, habitual constipation or diarrhea.
- History of pancreatitis.
- Major surgery within 6 months or unhealed surgical incisions.
- Blood donation within 3 months, blood transfusion or blood loss 65200ml within 4 weeks.
- Participation in 4 or more clinical trials in the past year or investigational drug/device use within 3 months.
- History of drug abuse within 5 years or drug use within 3 months.
- Use of prescription, OTC drugs, supplements, or herbal medicines within 4 weeks.
- Use of drugs causing QT/QTc prolongation or risk of torsades de pointes within 4 weeks.
- History of electrolyte imbalances (potassium, magnesium, calcium).
- Vaccination within 3 months or planned vaccination during the study.
- History of fainting at sight of blood or needles.
- Neurological, mental, respiratory, cardiovascular, digestive, hematological, endocrine, musculoskeletal, urinary, or other diseases affecting study results.
- History or risk factors for torsades de pointes or cardiac conduction abnormalities.
- ECG abnormalities exceeding defined limits or clinically significant.
- Laboratory test abnormalities outside defined limits.
- Positive for hepatitis B, hepatitis C, HIV, or syphilis antibodies.
- Positive breath alcohol or urine drug screening at baseline.
- Special dietary requirements or inability to follow diet restrictions.
- Consumption of special diets or vigorous exercise within 48 hours before dosing.
- Frequent alcohol consumption above defined limits or inability to abstain during trial.
- Smoking more than 5 cigarettes per day or tobacco use during trial.
- Pregnant, lactating, or positive pregnancy test.
- Use of oral contraceptives within 30 days or long-acting hormonal contraceptives within 6 months.
- Unprotected sexual intercourse within 14 days before screening for females of childbearing age.
- Plan to conceive or unwillingness to use effective contraception during and one year after the trial.
- Poor compliance or factors making participation unsuitable.
- Investigator, their family, research center personnel, sponsor employees, students, subordinates, or vulnerable participants.
- Possible inability to complete the study for other reasons.
AI-Screening
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Trial Site Locations
Total: 1 location
1
PKUCare Luzhong Hospital
Zibo, Shandong, China
Actively Recruiting
Research Team
J
Jie Hou
CONTACT
W
Wei Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
3
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