This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability and pharmacokinetics of multiple doses of LW402 tablets in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
LW402 Tablets
LW402 Placebo Tablets
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shangdong, China
Safety and Tolerability Assessment
Safety and Tolerability Assessment: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), along with abnormal clinical laboratory parameters, vital signs, physical examination findings, and 12-lead electrocardiogram (ECG) results.
Time frame: up to 9 days
Evaluate the PK characteristics
Measuring the level of LW402 and its primary metabolite in the blood.
Time frame: up to 9 days
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