NCT07162116

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Acute Myeloid Leukemia With FLT3/ITD Mutation

Interventions

Type	Name	Description
DRUG	XY0206	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)
DRUG	Moxifloxacin (400 mg)	400mg，On the morning of the day of dosing , subjects received moxifloxacin orally on an empty stomach
OTHER	XY0206 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)

Timeline

• Start date: 2025-07-06
• Primary completion: 2025-12-01
• Completion: 2026-05-01
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: China