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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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07695779
Enrollment
28
Registered
2026-07-10
Start date
2026-08-05
Completion date
2026-09-25
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of QTc Interval

Brief 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.

Interventions

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

DRUGPlacebo tablet

single dose, oral

Sponsors

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Effect on QTcF between baseline and post-dose treatment of FXS562645 min before administration and 24 hours after administrationThe Cmax geometric mean corresponds to the upper 90% bilateral confidence interval of ΔΔQTcF
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.Approximately 1 weekThe incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests

Secondary

MeasureTime frameDescription
Plasma concentration and pharmacokinetic parameters10 min before administration and 48 hours after administrationCmax

Countries

China

Contacts

CONTACTWei Xue, PHD
roserebel@126.com86 010-58115037
CONTACTWenyuan Qi
qiwenyuan.bjhmoh@gmail.com86 010-85138673

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026