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This is a Phase I, randomized, subject-blinded, placebo controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD),and food effect (FE) of HSK39297 following (1) a single ascending dose (part 1), (2) 10 days of multiple ascending dose (part 2), and (3) a single dose two-period crossover FE cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK39297 | Experimental | Single or multiple oral doses of HSK39297 |
|
| Placebo | Experimental | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK39297 | Drug | 50-600mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number and severity of treatment emergent adverse events (TEAEs) . | To assess the safety and tolerability of single or multiple oral dose of HSK39297 in healthy adult volunteers | 9 days after single dose and 16 days after the first dose of multiple doses |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | Area under the plasma concentration versus time curve (AUC) on Day 1 and D10 | Pre-dose to 168 hours post-dose |
| Cmax | The maximun plasma concentration of HSK39297 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital | Beijing | China |
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| Pre-dose to 168 hours post-dose |
| Tmax | Time of maximum concentration of HSK39297 | Pre-dose to 168 hours post-dose |
| t1/2 | half-life | Pre-dose to 168 hours post-dose |
| AP change | change from baselin of the alternative pathway activity | Pre-dose to 168 hours post-dose |
| Bb | change from baselin of the concentration of Bb | Pre-dose to 168 hours post-dose |