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The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS12192 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), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study use a randomized, open-label, two-period, two-crossover design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS12192 Cohort 1 | Experimental | Subjects receive a single dose of 50 mg CS12192 or matching placebo. |
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| CS12192 Cohort 2 | Experimental | Subjects receive a single dose of 150 mg CS12192 or matching placebo. |
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| CS12192 Cohort 3 | Experimental | Subjects receive a single dose of 200 mg CS12192 or matching placebo. |
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| CS12192 Cohort 4 | Experimental | Subjects receive a single dose of 300 mg CS12192 or matching placebo. |
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| CS12192 Cohort 5 | Experimental | Subjects receive a single dose of 400 mg CS12192 or matching placebo. |
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| CS12192 Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS12192 capsule | Drug | Participants receive CS12192 orally single or multiple doses |
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| Measure | Description | Time Frame |
|---|---|---|
| the Number of Adverse Events (AEs) | To investigate the safety and tolerability by assesment of AEs following administration. | up to 14 days |
| Pharmacokinetic parameters - Area Under the Curve(AUC) | Area Under the Plasma Concentration-time Curve of CS12192. | 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 the last dose for food effect study. |
| Pharmacokinetic parameters - Peak Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration of CS12192. | 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 the last dose for food effect study. |
| Pharmacokinetic parameters - Time of peak concentration(Tmax) | Time to reach maximum observed plasma concentration of CS12192. | 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 the last dose for food effect study. From time 0 to 48 hours after the last dose for food effect study. |
| Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2) | Plasma Elimination Half-Life of CS12192. | 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 the last dose for food effect study. From time 0 to 48 hours after the last dose 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), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study use a randomized, double-blind, placebo-controlled dose-escalation design. The FE study use a randomized, open-label, two-period, two-crossover design.
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Subjects receive 200 mg CS12192 or matching placebo for 7 days, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7. |
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| CS12192 Cohort 7 | Experimental | Subjects receive 300 mg CS12192 or matching placebo, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7. |
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| CS12192 Cohort 8 | Experimental | Subjects receive 400 mg CS12192 or matching placebo for 7 days, twice daily (every 12 h) from Day 1 to Day 6, and once on Day 7. |
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| CS12192 Cohort 9 | Experimental | Subjects receive a single dose 400 mg CS12192 in either the fasted or fed state for two periods. |
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| CS12192 Cohort 10 | Experimental | Subjects receive a single dose of 600 mg CS12192 or matching placebo. |
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| Placebo capsule | Drug | Participants receive placebo matching CS12192 orally single or multiple doses |
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