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RECRUITING
NCT07162116
PHASE1

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

Sponsor: Shijiazhuang Yiling Pharmaceutical Co. Ltd

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-07-06

Completion Date

2026-05

Last Updated

2025-09-09

Healthy Volunteers

Yes

Interventions

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)

Locations (1)

PKUCare Luzhong Hospital

Zibo, Shandong, China