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This is a phase I, randomised, double-blind placebo-controlled, 3-part study to assess the safety, tolerability, pharmacokinetics and food effect of single and multiple oral doses of XH-S004 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XH-S004 | Experimental | Participants will receive XH-S004 as per assigned treatment regimen on scheduled days. Starting dose in single asceding dose: 5 mg. |
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| XH-S004 placebo tablet | Placebo Comparator | Participants will receive matching placebo as per assigned treatment regimen on scheduled days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XH-S004 tablet | Drug | XH-S004 tablets will be administered orally as per assigned treatment regimen on schedualed days. |
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| Measure | Description | Time Frame |
|---|---|---|
| To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [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. | Approximately 1~2 weeks. |
| To access the incidence and severity of adverse events (AEs), serious AEs and abnormalities on laboratory tests [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. | Approximately 2 months. |
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Inclusive criteria:
Exclusive criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing LuHe Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
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| XH-S004 placebo tablet | Drug | XH-S004 placebo tablet (matched) will be administered orally as per assigned treatment regimen on schedualed days. |
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