QT Interval Effects Study of Oral FXS5626 Tablets

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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).

Disqualifiers

None

Trial design

Treatments tested in this trial

  • FXS5626 tablet
  • Placebo tablet

Treatment groups

28 Participants
are divided into 2 treatment groups