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New leukemia drug candidate undergoes heart safety check

NCT ID NCT07162116

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial is testing whether a single dose of XY0206 tablets affects the heart's electrical activity (QTc interval) in 45 healthy Chinese adults. Participants are randomly assigned to receive XY0206, a placebo, or an active control (moxifloxacin). The study lasts 3 days and monitors heart rhythm, drug levels in blood, and vital signs. It does not test the drug's ability to treat leukemia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XY0206 tablets
What this could lead to
If successful, this study will show whether XY0206 is safe for the heart, supporting further testing in people with leukemia.
What could go wrong
This is an early Phase 1 safety study in healthy volunteers, not patients. It cannot prove the drug works against leukemia, and heart effects may still appear later.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participants voluntarily sign a written informed consent form. 2. Male or female; aged between 18 and 45 years old (inclusive). 3. Male participants weigh ≥ 50kg, female participants weigh ≥ 45kg, and their body mass index (BMI) is between 19.0 and 26.0 kg/m², inclusive. 4. Physical examination, laboratory tests, and all trial-related examinations (vital signs, electrocardiogram, chest X-ray, abdominal color Doppler ultrasound, etc.) at the screening stage are normal or have only minor abnormalities without clinical significance, and are deemed qualified by the clinical research doctor. 5. Participants can communicate well with the researchers and comply with the protocol requirements to complete the study. Exclusion Criteria: Medical history, past medical history, recent medication history: 1. Those with a history of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory systems, etc.), mental disorders, or drug dependence; 2. Those with a history of drug or food allergies, or specific allergies (such as asthma, urticaria, eczema, etc.); or those allergic to XY0206 tablets, moxifloxacin hydrochloride, or other fluoroquinolones, or the excipients contained therein; or those known to be allergic to FLT3 inhibitors; 3. Those with a history of difficulty swallowing or any gastrointestinal diseases (or gastrointestinal resection, etc.) that affect drug absorption; 4. Those with hemorrhoids or perianal diseases with regular/ongoing bleeding, irritable bowel syndrome, inflammatory bowel disease; or those with habitual constipation or diarrhea; 5. Those with a history of pancreatitis; 6. Those who have undergone major surgery within 6 months before screening or whose surgical incisions have not fully healed; major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia, or incisional biopsies or significant traumatic injuries; 7. Those who have donated blood within 3 months before screening, or plan to donate blood during this study, or have received blood transfusions or lost ≥200ml of blood within 4 weeks before screening; 8. Those who have participated in 4 or more clinical trials within the past year; or those who have participated in any clinical trials and received investigational drugs or devices within 3 months before this trial; 9. Those with a history of drug abuse within the past 5 years or have used drugs within 3 months before the trial; 10. Those who have taken any prescription drugs, over-the-counter drugs, vitamin products, health supplements, or herbal medicines within 4 weeks before screening or within 5 half-lives (if known), whichever is longer; or those who have taken any drugs known to cause QT/QTc interval prolongation or have a risk of causing torsades de pointes (TdP) within 4 weeks before screening; 11. Those with a history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia; 12. Those who have received vaccinations within 3 months before screening or plan to receive vaccinations during this study; 13. Those with a history of fainting at the sight of blood or needles and cannot tolerate venous catheterization; Health status: 14. Those with neurological, mental, respiratory, cardiovascular, digestive, hematological and lymphatic, endocrine, musculoskeletal, urinary, or any other diseases or physiological conditions that may affect the study results at the time of screening; 15. Those with a history of cardiovascular diseases or risk factors for torsades de pointes (TdP) at the time of screening, including but not limited to: unexplained syncope; heart failure; myocardial infarction; angina pectoris; atrial fibrillation, atrial flutter, atrial premature beats, ventricular premature beats, non-sustained or sustained ventricular tachycardia; bradycardia or sick sinus syndrome; personal or family history of any cardiac conduction abnormalities; long QT syndrome (LQTS) personal or family history; or a family history of sudden death; 16. Those with 12-lead electrocardiogram results exceeding the standard at the screening or baseline period: PR \> 200ms, QRS \> 110ms, HR \< 50 bpm, QTcF \> 450 ms (for both males and females); or those with abnormal electrocardiograms and the investigator deems the abnormalities clinically significant (such as atrioventricular block, potential bundle branch block, torsades de pointes (TdP), other types of ventricular tachycardia, ventricular fibrillation and ventricular flutter, clinically significant T-wave changes, or any 12-lead electrocardiogram results that may affect the QTc interval); 17. Those with laboratory test results meeting the following abnormal ranges at the screening or baseline period: a. Abnormal hematological indicators: i. White blood cells \< lower limit of normal (LLN); ii. Absolute neutrophil count \< LLN; iii. Platelet count \< LLN; iv. Hemoglobin \< LLN. b. Abnormal liver function: AST and/or ALT \> upper limit of normal (ULN), total bilirubin and/or direct bilirubin \> ULN; c. Creatinine \> ULN, creatine kinase \> ULN, creatine kinase isoenzyme \> ULN, lipase \> ULN, amylase \> ULN; d. Metabolic abnormalities: serum triglycerides \> 1.2 times ULN. 18. Participants with positive hepatitis B surface antigen and/or hepatitis B e antigen, positive hepatitis C antibody, positive human immunodeficiency virus antibody, or positive Treponema pallidum antibody during the screening period; 19. Participants with positive breath alcohol test or positive urine drug abuse screening at baseline; Lifestyle restrictions: 20. Participants with special dietary requirements who cannot adhere to the diet and corresponding regulations provided by the clinical research institution; 21. Participants who cannot control special diets (including pitaya, mango, grapefruit and/or xanthine diet, caffeine-containing foods or beverages, strong tea, etc.) during the trial; 22. Participants who have consumed special diets (including pitaya, mango, grapefruit and/or xanthine diet, caffeine-containing foods or beverages, strong tea, etc.) or engaged in vigorous exercise within 48 hours before administration, or have other factors that may affect drug absorption, distribution, metabolism, and excretion; 23. Participants who have consumed alcohol frequently in the 6 months prior to administration, i.e., more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcohol spirits or 150 mL of wine), or cannot stop alcohol intake during the trial; 24. Participants who smoke more than 5 cigarettes per day in the 3 months prior to administration, or will use any tobacco products during the trial; Contraception: 25. Pregnant or lactating women or those with positive pregnancy tests; 26. Participants who have used oral contraceptives within 30 days before screening (applicable to females only); 27. Participants who have used long-acting estrogen or progesterone injections or implants within 6 months before screening (applicable to females only); 28. Females of childbearing age who have had unprotected sexual intercourse with their partners within 14 days before screening; 29. Participants of childbearing age, male or female, who have a plan to conceive from the time of signing the informed consent form until one year after the end of the trial, or who do not agree to use effective contraceptive methods, or do not agree to avoid freezing or donating sperm/eggs. Other criteria: 30. Participants who are considered to have poor compliance or have any other factors that make them unsuitable for this trial by the investigator; 31. The investigator, their family members, and related personnel of the research center; 32. Students and subordinates of the investigator, employees of the sponsor, and other vulnerable participants; 33. Participants who may be unable to complete the study for other reasons.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • PKUCare Luzhong Hospital

    RECRUITING

    Zibo, Shandong, China

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