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.
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).
Medically healthy with no clinically significant medical history, physical examination,laboratory profiles, vital signs or ECG abnormalities , as deemed by the PI or designee.
Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
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).
None
Parallel
FXS5626 tablet
DrugFXS5626 75mg、250mg、400mg, single dose, oral
Placebo tablet
Drugsingle dose, oral
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
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
Plasma concentration and pharmacokinetic parameters
Cmax
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