QT Interval Effects Study of Oral FXS5626 Tablets

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Evaluation of QTc Interval
• Intervention / Treatment: Drug: FXS5626 tablet; Drug: Placebo tablet

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wei Xue, PHD; Phone Number: 86 010-58115037; Email: roserebel@126.com
• Study Contact Backup: Name: Wenyuan Qi; Phone Number: 86 010-85138673; Email: qiwenyuan.bjhmoh@gmail.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Hospital
      • Contact: Qingqing Wang; Phone Number: 86 010-58115037; Email: bjyygcp@vip.126.com
      • Contact: Haijuan Zhao; Phone Number: 86 010-85138673; Email: bjyygcp@vip.126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria：

1. Healthy, adult, male or female,18-45 years of age (inclusive), with a Body Mass Index (BMI) of 19.0-28.0 kg/m2 (inclusive),have a minimum weight of at least 50kg(male) or 45kg(female).
2. Medically healthy with no clinically significant medical history, physical examination,laboratory profiles, vital signs or ECG abnormalities , as deemed by the PI or designee.
3. Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
4. Female subjects of childbearing potential and male subjects with a partner of childbearing potential who voluntarily signed ICF should be no fertile, sperm/egg donation for 3 months from the beginning to the last dose, and voluntary use highly effective contraception (including partner) (non-drug contraception is required during the trial).

Exclusive Criteria:

1. Female subjects who are pregnant,or breastfeeding,or with a positive pregnancy test
2. Allergic constitutions (such as allergies to two or more drugs, foods, and pollen), or determined by the investigator, may be allergic to the investigational product or any component of the investigational product.
3. Subjects with a prior or present history of clinically abnormal metabolic, liver, kidney, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, or psychiatric disease who were judged by the investigator to be unsuitable for participation in this study.
4. Subjects who have a history of other risk factors for tachycardia, or a family history of a first-degree relative (i.e. biological parent, sibling, or child) of short QT syndrome, long QT syndrome, or sudden unexplained death in young age (≤40 years).
5. Significant screening ECG abnormalities,QTcF interval > 450ms (Fridericia's correction), or QRS>120ms,or PR interval >=210ms or <=120ms
6. Subjects who have got severe infections within 2 months before screening; Or have a history of active bacterial infection or viral infection or fungal infection within 2 weeks before screening
7. Subjects virus serological test (hepatitis B virus surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum specific antibody TPPA) positive results.
8. Subjects with a history of drug abuse,or who screened positive for drug abuse.
9. Subjects who consumed more than 14 units of alcohol per week in the 6 months prior before screening (1 unit of alcohol =360mL beer or 45mL spirits with 40% alcohol or 150mL wine) or had a positive alcohol breath test or could not abstain during the trial.
10. Subjects who smoked more than 5 cigarettes per day in the 6 months prior before screening or could not give up during the trial.
11. Subjects who have abnormal laboratory test: neutrophil count<1.5 x10^9/L,or white blood cell count<3.5 x10^9/L,or creatine kinase greater than the upper limit of normal at screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FXS5626; FXS5626 75mg、250mg、400mg; single dose, oral	Drug: FXS5626 tablet; FXS5626 75mg、250mg、400mg, single dose, oral
Placebo Comparator: Placebo; single dose, oral	Drug: Placebo tablet; single dose, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect on QTcF between baseline and post-dose treatment of FXS5626	The Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF	45 min before administration and 24 hours after administration
To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [Safety and Tolerability] of single ascending oral dose of FXS5626 in healthy adults.	The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests	Approximately 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration and pharmacokinetic parameters	Cmax	10 min before administration and 48 hours after administration

Collaborators and Investigators

• Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 5, 2026
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): September 25, 2026

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FXS5626-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No