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The study is being conducted to evaluate the safety and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK/PD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level:A1(Part1) | Experimental | Subject will receive HRS-2162 at dose level A1. Subject will receive placebo at dose level A1. |
|
| Dose Level:A2(Part1) . | Experimental | Subject will receive HRS-2162 at dose level A2. Subject will receive placebo at dose level A2. |
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| Dose Level:B(Part1+Part2) | Experimental | Subject will receive HRS-2162 at dose level B. Subject will receive placebo at dose level B. |
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| Dose Level:C(Part1) | Experimental | Subject will receive HRS-2162 at dose level C. Subject will receive placebo at dose level C. |
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| Dose Level:D(Part1+Part3) | Experimental | Subject will receive HRS-2162 at dose level D. Subject will receive placebo at dose level D. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2162 | Drug | HRS-2162 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events | From ICF signing date to Day7 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed concentration of HRS-2162 (Cmax) | 0 hour to 24 hour after administration | |
| Area under the serum concentration time curve (AUC) of HRS-2162 | 0 hour to 24 hour after administration |
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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 |
|---|---|---|---|---|---|---|
| Sichuan Academy of Medical Sciences &Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | 610072 | China |
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| Dose Level:E(Part1) |
| Experimental |
Subject will receive HRS-2162 at dose level E. Subject will receive placebo at dose level E. |
|
| Dose Level:F(Part3) | Experimental | Subject will receive HRS-2162 at dose level F |
|
| Placebo | Drug | Placebo |
|
| Time to maximum observed concentration (Tmax) of HRS-2162 | 0 hour to 24 hour after administration |
| Half-life (T1/2) of HRS-2162 | 0 hour to 24 hour after administration |
| Clearance (CL) of HRS-2162 | 0 hour to 24 hour after administration |
| Volume of distribution (Vz) of HRS-2162 | 0 hour to 24 hour after administration |
| Efficacy endpoint: The time required from the administration of the investigational drug to the recovery of the TOFr value (T4/T1 value) | 0 hour to 1 hour after administration |