The purpose of the study is to assess the safety, tolerability and pharmacokinetics of XH-S002 in healthy volunteers under SAD (Single ascending dose) and MAD (Multiple ascending dose) studies. In addition, this study evaluates the food effects of XH-S002.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
86
XH-S002 powder will be administered orally as per assigned treatment regimen.
XH-S002 Placebo (matched) will be administered orally as per assigned treatment regimen.
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGTo access the safety and tolerability of single ascending dosed of XH-S002 in healthy adults.
Safety and tolerability of single dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.
Time frame: Approximately 1~2weeks
To access the safety and tolerability of multiple ascending dosed of XH-S002 in healthy adults.
Safety and tolerability of multiple dose of XH-S002 measured by number of subjects who experience AEs and potential clinically significant changes in clinical symptoms, vital signs, physical examinations, laboratory tests and ECG parameters.
Time frame: Approximately 1~2weeks
Beijing Friendship Hospital, Capital Medical University
CONTACT
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