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The purpose of this study is to evaluate the efficacy and safety of HRS-9231 for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI); to explore the effective dose of HRS-9231 for CNS MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in CNS MRI subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-9231 dose 1 | Experimental |
| |
| HRS-9231 dose 2 | Experimental |
| |
| HRS-9231 dose 3 | Experimental |
| |
| Gadobutrol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9231 | Drug | HRS-9231 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Calculate the Contrast-to-Noise Ratio (CNR) based on the Signal Intensity (SI) of CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol) | 1 day procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Medical applicability of MRI imaging for CNS lesions after receiving HRS-9231 or the control drug (Gadobutrol). | 1 day procedure | |
| Number, size, and location of CNS lesions in MRI images after receiving HRS-9231 or the control drug. | 1 day procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junpeng Zhuang | Contact | +0518-82342973 | junpeng.zhuang.jz5@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People's Hospital, Peking University | Beijing | Beijing Municipality | 100000 | China |
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| Gadobutrol |
| Drug |
Gadobutrol |
|
| Visualization scores for CNS lesions in MRI images after receiving HRS-9231 or the control drug (Gadobutrol): boundary delineation, internal morphology, and contrast enhancement. | 1 day procedure |
| HRS-9231 plasma concentration and population pharmacokinetic parameters (such as clearance, apparent volume of distribution, etc.). | 1 day procedure |
| ID | Term |
|---|---|
| C090600 | gadobutrol |
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