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

NCT07162116 | Recruiting Phase 1

• 1 other identifier: XY0206AML1007
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Myeloid Leukemia With FLT3/ITD Mutation

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours after drug administration

Secondary Outcomes (1)

• blood sample

  48 hours after drug administration

Study Arms (3)

XY0206

EXPERIMENTAL

12.5 mg/tablet,single dose,administer according to the administration methods of groups A, B, and C.

Drug: XY0206

Moxifloxacin

ACTIVE COMPARATOR

400mg/tablet,single dose

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.

Other: XY0206 Placebo

Interventions

XY0206 DRUG

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)

XY0206

Moxifloxacin (400 mg) DRUG

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

Moxifloxacin

XY0206 Placebo OTHER

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)

XY0206 Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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:

Sponsors & Collaborators

• Shijiazhuang Yiling Pharmaceutical Co. Ltd: lead

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, Shandong, China

RECRUITING

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Jie Hou

CONTACT

+86 0533-7698397; jie.hou@gohealtharo.com

Wei Wang

CONTACT

086-0311-66703017; wangwei001@yiling.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 9, 2025
• Study Start: July 6, 2025
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)