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This is a randomized, placebo-controlled, single & multiple dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 5 mg followed by dose escalation groups up to 100 mg. Healthy Chinese subjects will be randomized in each cohort to receive the study drug or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-test | Experimental | Three healthy male subjects were randomized in 2:1 ratio to receive single and then multiple (14 days) oral dose of 5 mg SHR0534 or matching placebo. |
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| Cohort 1 | Experimental | Eight healthy subjects were randomized in 3:1 ratio to receive single and then multiple (14 days) oral dose of 5 mg SHR0534 or matching placebo. |
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| Cohort 2 | Experimental | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 10 mg SHR0534 or matching placebo. |
|
| Cohort 3 | Experimental | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 25 mg SHR0534 or matching placebo. |
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| Cohort 4 | Experimental | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 50 mg SHR0534 or matching placebo. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0534 | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From baseline up to 8 days after last treatment (Day 31) |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma or urine concentration curve after single or the last multiple oral dose (AUC) | From time 0 to 168 hours for single dose, and from time 0 to 192 hours after the last dose | |
| Peak plasma concentration (Cmax) after single or the last multiple oral dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Cohort 5 | Experimental | Ten healthy subjects were randomized in 4:1 ratio to receive single and then multiple (14 days) oral dose of 100 mg SHR0534 or matching placebo. |
|
| Placebo |
| Drug |
|
| From time 0 to 168 hours for single dose, and from time 0 to 192 hours after the last dose |
| Terminal elimination halflife (t½) for SHR0534 after single or the last multiple oral dose | From time 0 to 168 hours for single dose, and from time 0 to 192 hours after the last dose |
| Changes in the concentrations of blood glucose and insulin after single or multiple oral dose | From baseline up to 24 hours after last treatment (Day 24) |
| ID | Term |
|---|---|
| C000715114 | SHR0534 |
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