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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose 200mg | Experimental | LW402 200 mg, PO BID |
|
| Dose 250mg | Experimental | LW402 250 mg, PO BID |
|
| Dose 300mg | Experimental | LW402 300 mg, PO BID |
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| Placebo Dose 200mg | Placebo Comparator | LW402 placebo tablets,200 mg, PO BID |
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| Placebo Dose 250mg | Placebo Comparator | LW402 Placebo Tablets,250 mg, PO BID |
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| Placebo Dose 300mg | Placebo Comparator | LW402 Placebo Tablets,300mg,BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental | Drug | LW402 Tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the PK characteristics | Measuring the level of LW402 and its primary metabolite in the blood. | up to 9 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wei Zhao | Shandong First Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University | Jinan | Shangdong | China |
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| Placebo |
| Drug |
LW402 Placebo Tablets |
|