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The objective of this multicenter, open, single-dose, parallel controlled, Phase I clinical study is to Evaluate a single oral ZX-7101A PK in subjects with varying degrees of (mild or moderate) liver insufficiency compared with healthy subjects matched by age, weight, and sex. And to evaluate the the safety and tolerability of ZX-7101A by a single oral dose in subjects.
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZX-7101A 80mg Mild or moderate liver insufficiency | Experimental |
| |
| ZX-7101A 80mg Normal liver function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZX-7101A 80mg | Drug | ZX-7101A a drug to treatment influenza in Chinese adults |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | To evaluate the peak concentration of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency | From dosing to 15 days after medication |
| AUC | To evaluate the area under curve of ZX-7101A after a single oral administration in subjects with mild and moderate hepatic insufficiency | From dosing to 15 days after medication |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 after a single oral administration ZX-7101A | The Number of Participants with Treatment-Related Adverse Events will be evaluated as the change of vital signs, electrocardiogram (P Wave, QRS Complex, QT Interval), physical examination, and Laboratory test compared with the baseline. | From dosing to 29 days after medication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian yu huang, doctor | Huashan Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shuguang Hospital, Shanghai University of Traditional Chinese Medicine | Shanghai | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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80mg ZX-7101A
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |