Acute Myeloid Leukemia With FLT3/ITD MutationPhase 1XY0206-CQTNCT07162116
A Study to Evaluate the Effect of XY0206 on the QTc Interval in Chinese Healthy Participants
A Phase 1 study testing XY0206 and Moxifloxacin (400 mg) in people with Acute Myeloid Leukemia With FLT3/ITD Mutation, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia With FLT3/ITD Mutation
- What is being tested?
- XY0206 and Moxifloxacin (400 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2025to May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants voluntarily sign a written informed consent form.
- Male or female; aged between 18 and 45 years old (inclusive).
- Male participants weigh ≥ 50kg, female participants weigh ≥ 45kg, and their body mass index (BMI) is between 19.0 and 26.0 kg/m², inclusive.
- 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.
- Participants can communicate well with the researchers and comply with the protocol requirements to complete the study.
Who cannot join
- Medical history, past medical history, recent medication history:
- Those with a history of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory systems, etc.), mental disorders, or drug dependence;
- 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;
- Those with a history of difficulty swallowing or any gastrointestinal diseases (or gastrointestinal resection, etc.) that affect drug absorption;
- Those with hemorrhoids or perianal diseases with regular/ongoing bleeding, irritable bowel syndrome, inflammatory bowel disease; or those with habitual constipation or diarrhea;
- Those with a history of pancreatitis;
Show all 39Show fewer
- 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;
- 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;
- 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;
- Those with a history of drug abuse within the past 5 years or have used drugs within 3 months before the trial;
- 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;
- Those with a history of hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia, or hypocalcemia;
- Those who have received vaccinations within 3 months before screening or plan to receive vaccinations during this study;
- Those with a history of fainting at the sight of blood or needles and cannot tolerate venous catheterization;
- Health status:
- 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;
- 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;
- 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);
- Those with laboratory test results meeting the following abnormal ranges at the screening or baseline period:
- 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.
- 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;
- Participants with positive breath alcohol test or positive urine drug abuse screening at baseline;
- Lifestyle restrictions:
- Participants with special dietary requirements who cannot adhere to the diet and corresponding regulations provided by the clinical research institution;
- 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;
- 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;
- 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;
- 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:
- Pregnant or lactating women or those with positive pregnancy tests;
- Participants who have used oral contraceptives within 30 days before screening (applicable to females only);
- Participants who have used long-acting estrogen or progesterone injections or implants within 6 months before screening (applicable to females only);
- Females of childbearing age who have had unprotected sexual intercourse with their partners within 14 days before screening;
- 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:
- Participants who are considered to have poor compliance or have any other factors that make them unsuitable for this trial by the investigator;
- The investigator, their family members, and related personnel of the research center;
- Students and subordinates of the investigator, employees of the sponsor, and other vulnerable participants;
- Participants who may be unable to complete the study for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
PKUCare Luzhong Hospital
Zibo, Shandong
Zhaojun Wang, +86 0533-7698397, zhaojun.wang@gohealtharo.com
About this study
Official title: 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.
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.
Read the detailed description
The primary objective of this study is to evaluate the effect of a single oral dose of XY0206 tablets on the QT/QTc interval in healthy subjects, and to assess the pharmacokinetic (PK) characteristics of XY0206 in healthy humans and its impact on other ECG parameters (HR, PR, QRS interval, T-wave morphology and U-wave presence) in healthy subjects. Additionally, the safety and tolerability of a single oral dose of XY0206 tablets in healthy subjects will be evaluated. Moxifloxacin will be used as a positive control to assess the sensitivity and reliability of this clinical study. This study plans to enroll 45 (Groups A, B, and C) to 75 (including possible additional dose groups) healthy subjects. Group A (XY0206 tablets: 37.5 mg; moxifloxacin hydrochloride tablets: 400 mg; XY0206 placebo: 37.5 mg); Group B (XY0206 tablets: 75 mg; moxifloxacin hydrochloride tablets: 400 mg; XY0206 placebo: 75 mg); Group C (XY0206 tablets: 150 mg; moxifloxacin hydrochloride tablets: 400 mg; XY0206 placebo: 150 mg), with 15 subjects in each group (9 XY0206 tablets, 3 moxifloxacin hydrochloride tablets, and 3 XY0206 placebos). Groups B, C, and possible additional dose groups will follow the "sentinel dosing" approach. Subjects will fast for at least 10 hours the night before dosing. On Day 1, participants will be administered XY0206 tablets, moxifloxacin hydrochloride tablets, or placebo according to the randomization table. XY0206 tablets and placebo will be administered in a double-blind manner, while moxifloxacin hydrochloride tablets will be administered in an open-label manner. Participants will undergo Holter monitoring, PK sample collection, and safety assessment within the specified time frame.
- Being tested
- XY0206, Moxifloxacin (400 mg), XY0206 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XY0206Drug
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)
Moxifloxacin (400 mg)Drug
400mg，On the morning of the day of dosing , subjects received moxifloxacin orally on an empty stomach
XY0206 PlaceboOther
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)
| Study group | Role | What they receive |
|---|---|---|
| XY0206 | Experimental | 12.5 mg/tablet,single dose,administer according to the administration methods of groups A, B, and C. Receives: Drug: XY0206 |
| Moxifloxacin | Active comparator | 400mg/tablet,single dose Receives: Drug: Moxifloxacin (400 mg) |
| XY0206 Placebo | Placebo comparator | 12.5 mg/tablet,single dose,administer according to the administration methods of groups A, B, and C. Receives: Other: XY0206 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT/QTc
Holter ECG data of each study participant from 1 hour before administration to 48 hours after administration were collected, and data were extracted according to the collection point to evaluate the effect of a single dose of XY0206 tablets/placebo/moxifloxacin on the QT/QTc interval of healthy people
Measured: 48 hours after drug administration
Secondary outcomes (1)
blood sample
Blood concentration is measured
Measured: 48 hours after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start6 Jul 2025
- Primary completion1 Dec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia With FLT3/ITD MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162116
- Sponsor's protocol ID
- XY0206AML1007
- Acronym
- XY0206-CQT
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07162116
- Acronym / sponsor ID
- XY0206-CQT / XY0206AML1007
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to evaluate the effect of a single oral dose of XY0206 tablets on the QT/QTc interval in healthy subjects, and to assess the pharmacokinetic (PK) characteristics of XY0206 in healthy humans and its impact on other ECG parameters (HR, PR, QRS interval, T-wave morphology and U-wave presence) in healthy subjects. Additionally, the safety and tolerability of a single oral dose of XY0206 tablets in healthy subjects will be evaluated. Moxifloxacin will be used as a positive control to assess the sensitivity and reliability of this clinical study. This study plans to enroll 45 (Groups A, B, and C) to 75 (including possible additional dose groups) healthy subjects. Group A (XY0206 tablets: 37.5 mg; moxifloxacin hydrochloride tablets: 400 mg; XY0206 placebo: 37.5 mg); Group B (XY0206 tablets: 75 mg; moxifloxacin hydrochloride tablets: 400 mg; XY0206 placebo: 75 mg); Group C (XY0206 tablets: 150 mg; moxifloxacin hydrochloride tablets: 400 mg; XY0206 placebo: 150 mg), with 15 subjects in each group (9 XY0206 tablets, 3 moxifloxacin hydrochloride tablets, and 3 XY0206 placebos). Groups B, C, and possible additional dose groups will follow the "sentinel dosing" approach. Subjects will fast for at least 10 hours the night before dosing. On Day 1, participants will be administered XY0206 tablets, moxifloxacin hydrochloride tablets, or placebo according to the randomization table. XY0206 tablets and placebo will be administered in a double-blind manner, while moxifloxacin hydrochloride tablets will be administered in an open-label manner. Participants will undergo Holter monitoring, PK sample collection, and safety assessment within the specified time frame.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| XY0206 | Experimental | Drug: XY020612.5 mg/tablet,single dose,administer according to the administration methods of groups A, B, and C. |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin (400 mg)400mg/tablet,single dose |
| XY0206 Placebo | Placebo comparator | Other: XY0206 Placebo12.5 mg/tablet,single dose,administer according to the administration methods of groups A, B, and C. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants voluntarily sign a written informed consent form.
- Male or female; aged between 18 and 45 years old (inclusive).
- Male participants weigh ≥ 50kg, female participants weigh ≥ 45kg, and their body mass index (BMI) is between 19.0 and 26.0 kg/m², inclusive.
- 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.
- Participants can communicate well with the researchers and comply with the protocol requirements to complete the study.
Key exclusion criteria (39 listed)
- Those with a history of severe systemic diseases (including cardiovascular, digestive, urinary, respiratory systems, etc.), mental disorders, or drug dependence;
- 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;
- Those with a history of difficulty swallowing or any gastrointestinal diseases (or gastrointestinal resection, etc.) that affect drug absorption;
- Those with hemorrhoids or perianal diseases with regular/ongoing bleeding, irritable bowel syndrome, inflammatory bowel disease; or those with habitual constipation or diarrhea;
- Those with a history of pancreatitis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XY020612.5 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) | Drug | XY0206 |
| Moxifloxacin (400 mg)400mg，On the morning of the day of dosing , subjects received moxifloxacin orally on an empty stomach | Drug | Moxifloxacin |
| XY0206 Placebo12.5mg/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) | Other | XY0206 Placebo |
Primary outcome
QT/QTc
Time frame: 48 hours after drug administration
Holter ECG data of each study participant from 1 hour before administration to 48 hours after administration were collected, and data were extracted according to the collection point to evaluate the effect of a single dose of XY0206 tablets/placebo/moxifloxacin on the QT/QTc interval of healthy people
1 secondary outcome
blood sample
Time frame: 48 hours after drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XY0206 and Moxifloxacin (400 mg) in people with Acute Myeloid Leukemia With FLT3/ITD Mutation, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Hou (+86 0533-7698397, jie.hou@gohealtharo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QT/QTc (time frame: 48 hours after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.