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RECRUITING
NCT07695779
PHASE1

QT Interval Effects Study of Oral FXS5626 Tablets

Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the Exposure-Response Relationship Between the Plasma Drug Concentrations and the Change From Baseline in QTc interval of a single oral dose of FXS5626 in healthy subjects.

Official title: A Single-Center, Double-Blind, Placebo-Controlled, Dose-Escalating Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and QT Interval Effects of Oral FXS5626 Tablets in Healthy Chinese Participants

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

28

Start Date

2026-08-13

Completion Date

2027-01-22

Last Updated

2026-10-14

Healthy Volunteers

Yes

Interventions

DRUG

FXS5626 tablet

FXS5626 75mg、250mg、400mg, single dose, oral

DRUG

Placebo tablet

single dose, oral

Locations (1)

Beijing Hospital

Beijing, Beijing Municipality, China