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This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HRS-6257 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-6257 group | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6257 | Drug | HRS-6257 |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events | from ICF signing date to Day 14 or Day 21 or Day 27 |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of HRS-6257 | 0 hour to 72 hour after administration | |
| Cmax of HRS-6257 | 0 hour to 72 hour after administration | |
| Tmax of HRS-6257 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanyuan Huang | Contact | +0518-82342973 | yuanyuan.huang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
placebo |
|
| 0 hour to 72 hour after administration |
| t1/2 of HRS-6257 | 0 hour to 72 hour after administration |
| CL/F of HRS-6257 | 0 hour to 72 hour after administration |
| Vz/F of HRS-6257 | 0 hour to 72 hour after administration |
| Pain tolerance time for the Cold Pain Test | Day 1 to Day 1 or Day 14 |
| Number of Participants With Clinically Meaningful Findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | from ICF signing date to Day 14 |