This is a phase I, randomised, double-blind placebo-controlled, 3-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of XH-S004 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
106
XH-S004 tablets will be administered orally as per assigned treatment regimen on schedualed days
Matching placebo tablets will be administered orally as per assigned treatment regimen on schedualed days
Beijing LuHe Hospital, Capital Medical University
Beijing, Beijing Municipality, China
To access the safety and tolerability of single ascending oral dose of XH-S004 in healthy adults.
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests.
Time frame: Approximately 1~2 weeks.
To access the safety and tolerability of multiple ascending oral dose of XH-S004 in healthy adults.
The incidence and severity of adverse events (AEs) , serious AEs and abnormalities on laboratory tests.
Time frame: Approximately 2 months.
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