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This is a randomized, placebo-controlled, single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The study will be conducted with starting dose of 10 mg followed by dose escalation groups up to 200 mg. Eight subjects will be randomized in 3:1 ratio in each cohort to receive the study drug or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Single oral dose of 10 mg SHR0534 or matching placebo |
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| Cohort 2 | Experimental | Single oral dose of 25 mg SHR0534 or matching placebo |
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| Cohort 3 | Experimental | Single oral dose of 50 mg SHR0534 or matching placebo |
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| Cohort 4 | Experimental | Single oral dose of 100 mg SHR0534 or matching placebo |
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| Cohort 5 | Experimental | Single oral dose of 200 mg SHR0534 or matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0534 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events (TEAEs) | From baseline up to 8 days after single dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration curve (AUC) | From time 0 to 168 hours after single dose | |
| Peak plasma concentration (Cmax) after dose after dose | From time 0 to 168 hours after single dose | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Ruff, M.D | ICON Development Solutions | Principal Investigator |
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| Drug |
|
| Terminal elimination halflife (t½) for SHR0534 after single dose after dose |
| From time 0 to 168 hours after single dose |
| Changes in the concentrations of blood glucose after SHR0534 is orally administered | From baseline up to 8 hours after single dose |
| ID | Term |
|---|---|
| C000715114 | SHR0534 |
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