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The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS32582 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects.
This study consists of 3 parts: single ascending dose (SAD), food effect (FE) and multiple ascending dose (MAD). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study is a randomized, open-label, two-period, two-crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS32582 Cohort 1 | Experimental | Subjects receive a single dose of 3 mg CS32582 or matching placebo |
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| CS32582 Cohort 2 | Experimental | Subjects receive a single dose of 6 mg CS32582 or matching placebo |
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| CS32582 Cohort 3 | Experimental | Subjects receive a single dose of 12 mg CS32582 or matching placebo |
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| CS32582 Cohort 4 | Experimental | Subjects receive a single dose of 24 mg CS32582 or matching placebo |
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| CS32582 Cohort 5 | Experimental | Subjects receive a single dose of 36 mg CS32582 or matching placebo |
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| CS32582 Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS32582 capsule | Drug | Participants receive CS32582 orally single or multiple doses |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events (AEs) | To investigate the safety and tolerability by assessment of AEs following administration. | From the time of signing the informed consent form to 7 days after the last administration of the drug |
| Pharmacokinetic parameters - Area Under the Curve(AUC) | Area Under the Plasma Concentration-time Curve of CS32582. | From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study. |
| Pharmacokinetic parameters - Peak Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration of CS32582. | From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study. |
| Pharmacokinetic parameters - Time of Peak Concentration(Tmax) | Time to reach maximum observed plasma concentration of CS32582. | From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study. |
| Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2) | Plasma Elimination Half-Life of CS32582. | From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after each period's dosing for food effect study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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The study consists of 3 parts: single ascending dose (SAD), food effect (FE) and multiple ascending dose (MAD). Both SAD and MAD study are a randomized, double-blind, placebo-controlled dose-escalation design. The FE study is a randomized, open-label, two-period, two-crossover design.
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Subjects receive a single dose of 54 mg CS32582 or matching placebo |
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| CS32582 Cohort 7 | Experimental | Subjects receive a single dose 12 mg CS32582 in either the fasted or fed state for two periods |
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| CS32582 Cohort 8 | Experimental | Subjects receive 3 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10. |
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| CS32582 Cohort 9 | Experimental | Subjects receive 6 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10. |
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| CS32582 Cohort 10 | Experimental | Subjects receive 12 mg CS32582 or matching placebo for 10 days, once daily from Day 1 to Day 10. |
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| CS32582 Cohort 11 | Experimental | Subjects receive 12 mg CS32582 or matching placebo for 10 days, twice daily (every 12 h) from Day 1 to Day 9, and once on Day 10. |
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| Placebo capsule | Drug | Participants receive placebo matching CS32582 orally single or multiple doses |
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