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| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK21542 0.2 μg/kg(15 min) | Experimental | Healthy volunteers 0.2 μg/kg HSK21542 |
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| HSK21542 0.5 μg/kg | Experimental | Healthy volunteers 0.5 μg/kg HSK21542 or Placebo |
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| HSK21542 1 μg/kg (15min) | Experimental | Healthy volunteers 1 μg/kg HSK21542 or Placebo |
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| HSK21542 1 μg/kg (2min) | Experimental | Healthy volunteers 1 μg/kg HSK21542 or Placebo |
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| HSK21542 0.75 μg/kg | Experimental | Healthy volunteers 0.75 μg/kg HSK21542 or Placebo |
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| HSK21542 1.5 μg/kg | Experimental | Healthy volunteers 1.5 μg/kg HSK21542 or Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK21542 | Drug | Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. |
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| Measure | Description | Time Frame |
|---|---|---|
| AE/serious AE | Adverse event/serious adverse event | From screening up to 3 weeks |
| Vital signs: Systolic and Diastolic Blood Pressure | Vital signs (Systolic and Diastolic Blood Pressure) will be collected in healthy volunteers. | From screening up to 3 weeks |
| Ramsay sedation score | Ramsay sedation score will be collected | -60 minutes before administration until 24 hours after administration |
| Visual analog scale (VAS) addiction score | VAS addiction score will be collected | from administration to 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Peak concentration (Cmax) | Cmax(a measure of the body's exposure to HSK21542)will be calculated in healthy volunteers. | -30 minutes before administration until 24 hours after administration |
| Area under the concentration-time curve(AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Yan, PhD | The Second Affiliated Hospital of Zhejiang University Medical College | Study Director |
| Hong-gang Lou, PhD | The Second Affiliated Hospital of Zhejiang University Medical College | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18246198 | Result | Zollner C, Mousa SA, Fischer O, Rittner HL, Shaqura M, Brack A, Shakibaei M, Binder W, Urban F, Stein C, Schafer M. Chronic morphine use does not induce peripheral tolerance in a rat model of inflammatory pain. J Clin Invest. 2008 Mar;118(3):1065-73. doi: 10.1172/JCI25911. |
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| HSK21542 2.25 μg/kg | Experimental | Healthy volunteers 2.25 μg/kg HSK21542 or Placebo |
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| HSK21542 3.375 μg/kg | Experimental | Healthy volunteers 3.375 μg/kg HSK21542 or Placebo |
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| HSK21542 0.2 μg/kg(2min) | Experimental | Healthy volunteers 0.2 μg/kg HSK21542 or Placebo |
|
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| HSK21542 | Drug | Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. |
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| HSK21542 | Drug | Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. |
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| HSK21542 | Drug | Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min. |
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| HSK21542 | Drug | Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. |
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| HSK21542 | Drug | Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. |
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| HSK21542 | Drug | Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. |
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| HSK21542 | Drug | Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min. |
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| HSK21542 | Drug | Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min. |
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AUC(a measure of the body's exposure to HSK21542)will be calculated in healthy volunteers.
| -30 minutes before administration until 24 hours after administration |
| Tmax | time to peak observed | -30 minutes before administration until 24 hours after administration |
| Total clearance | Total clearance | -30 minutes before administration until 24 hours after administration |
| Prolactin level | Prolactin level will be collected | before administration until 24 hours after administration |
| Antidiuretic hormone level | Antidiuretic hormone level will be collected | before administration until 24 hours after administration |
| Urine volume | Urine volume will be collected | before administration until 24 hours after administration |