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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics in healthy subjects, and to evaluate the food effect on pharmacokinetics of HRS-2129.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment at dose level 1 | Experimental |
| |
| Treatment at dose level 2 | Experimental |
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| Treatment at dose level 3 | Experimental |
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| Treatment at dose level 4 | Experimental |
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| Treatment at dose level 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2129 | Drug | HRS-2129 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events | from ICF signing date to day 28 since last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of HRS-2129: Cmax | 0 hour to 216 hour after administration | |
| Pharmacokinetic parameter of HRS-2129: AUC0-t | 0 hour to 216 hour after administration | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | 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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HRS-2129 for dose escalation
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| HRS-2129 Placebo | Drug | HRS-2129 Placebo |
|
| Pharmacokinetic parameter of HRS-2129: AUC0-inf |
| 0 hour to 216 hour after administration |
| Pharmacokinetic parameter of HRS-2129: Tmax | 0 hour to 216 hour after administration |
| Pharmacokinetic parameter of HRS-2129: t1/2 | 0 hour to 216 hour after administration |
| Pharmacokinetic parameter of HRS-2129: CL/F | 0 hour to 216 hour after administration |
| Pharmacokinetic parameter of HRS-2129: Vz/F | 0 hour to 216 hour after administration |
| Electrocardiogram measurement: QTcF interval | 90 minute predose to 48 hour after administration |
| Pain detection threshold for the Thermode Cold Test | 0 hour to 12 hour after administration |
| Pain tolerance time for the Thermode Cold Test | 0 hour to 12 hour after administration |