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This is a single-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797 in Chinese adults. To evaluate the effect of IV infusion duration on the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797. To explore the ED95 dosage of HRS3797 in Chinese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A1 | Experimental | HRS3797 for injection |
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| Treatment group A2 | Experimental | HRS3797 for injection |
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| Treatment group B1 | Experimental | HRS3797 for injection |
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| Treatment group B2 | Experimental | HRS3797 for injection |
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| Treatment group C1 | Experimental | HRS3797 for injection |
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| Treatment group C2 | Experimental | HRS3797 for injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS3797 | Drug | HRS3797 for injection, low dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum T1 Suppression | 0 minute to full neuromuscular recovery after administration | |
| Time to Maximum T1 Suppression | 0 minute to full neuromuscular recovery after administration | |
| The onset of neuromuscular block | 0 minute to full neuromuscular recovery after administration | |
| The duration of neuromuscular block | 0 minute to full neuromuscular recovery after administration | |
| The recovery rate of neuromuscular block | 0 minute to full neuromuscular recovery after administration | |
| Pharmacokinetic parameter of HRS3797: Cmax | 0 minute to 1.5 hour after administration | |
| Pharmacokinetic parameter of HRS3797: AUC0-t | 0 minute to 1.5 hour after administration | |
| Pharmacokinetic parameter of HRS3797: AUC0-∞ | 0 minute to 1.5 hour after administration | |
| Pharmacokinetic parameter of HRS3797: Tmax | 0 minute to 1.5 hour after administration | |
| Pharmacokinetic parameter of HRS3797: t1/2z | 0 minute to 1.5 hour after administration |
| Measure | Description | Time Frame |
|---|---|---|
| The ED95 dosage | 0 minute to full neuromuscular recovery 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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HRS3797 for dose escalation
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| HRS3797 |
| Drug |
HRS3797 for injection, medium dose |
|
| HRS3797 | Drug | HRS3797 for injection, high dose |
|
| Pharmacokinetic parameter of HRS3797: CLz | 0 minute to 1.5 hour after administration |
| Pharmacokinetic parameter of HRS3797: Vz | 0 minute to 1.5 hour after administration |
| The change of plasma histamine concentration from baseline | 0 minute to 1 hour after administration |
| The incidence and severity of adverse events/serious adverse events | from ICF signing date to day 28 |