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The purpose of this study is to evaluate the effect of a single oral dose of ZX-7101A on the QTc interval in healthy subjects.
Day 1, Oral fasting administration of ZX-7101A tablets 80mg, 160mg and placebo, 6 visit periods were set from days 2 to 15(Day2, Day3, Day5, Day7, Day10, Day15)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 80mg group | Experimental | D1, two 40mg tablets and two placebo tablets |
|
| 160mg group | Experimental | D1, four 40mg tablets |
|
| Placebo group | Placebo Comparator | D1, 4 placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZX-7101A | Drug | a drug to treat influenza, oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ΔΔQTc -Placebo-corrected, baseline-adjusted QTc interval (ΔΔQTc) | Placebo-corrected, baseline-adjusted QTc interval (ΔΔQTc) at designed time after single oral administration of ZX-7101A tablets 80mg and 160mg in healthy Chinese adults. ΔΔQTc:The change of QTc interval from baseline value (ΔQTc) at each time point after administration was calculated, and then the difference of ΔQTc between the experimental group and the placebo group at each time point was calculated(ΔΔQTc). | Day1, Day2, Day3, Day5, Day7, Day10, Day15 |
| Measure | Description | Time Frame |
|---|---|---|
| T wave | T-wave morphology,or absence | Day1, Day2, Day3, Day5, Day7, Day10, Day15 |
| PK parameters | Cmax of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | 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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The investigational drug and the investigational drug placebo shall be provided by the sponsoring unit or its designated unit; Ensure that the placebo looks, tastes, and weighs similar to the test drug and marked for clinical trials; The test drug and placebo shall be blinded by the sponsor or its designated unit for each trial group.
| Placebo |
| Drug |
placebo control, oral |
|
| Day1, Day2, Day3, Day5, Day7, Day10, Day15 |
| TEAE | Rate of Treatment-Emergent Adverse Events(TEAE) | Day1, Day2, Day3, Day5, Day7, Day10, Day15 |
| U wave | U-wave presence and absence | Day1, Day2, Day3, Day5, Day7, Day10, Day15 |
| PK parameters | AUC0-t of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug) | Day1, Day2, Day3, Day5, Day7, Day10, Day15 |
| PK parameters | AUCinf of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug) | Day1, Day2, Day3, Day5, Day7, Day10, Day15 |
| PK parameters | Tmax of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug) | Day1, Day2, Day3, Day5, Day7, Day10, Day15 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |