A Phase 1 interventional study of ZX-7101A and Placebo in Influenza, Human, sponsored by Nanjing Zenshine Pharmaceuticals. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by Nanjing Zenshine Pharmaceuticals · Phase 1, Interventional, and Treatment
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)
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 24 is below the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Nanjing Zenshine Pharmaceuticals is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
D1, two 40mg tablets and two placebo tablets
Drug: ZX-7101A · Drug: Placebo
D1, four 40mg tablets
Drug: ZX-7101A
D1, 4 placebo tablets
Drug: Placebo
a drug to treat influenza, oral
placebo control, oral
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).
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
T wave
T-wave morphology,or absence
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
Cmax of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
TEAE
Rate of Treatment-Emergent Adverse Events(TEAE)
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
U wave
U-wave presence and absence
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
AUC0-t of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
AUCinf of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
PK parameters
Tmax of prodrug ZX-7101A and active metabolite ZX-7101 (mother drug)
Time frame: Day1, Day2, Day3, Day5, Day7, Day10, Day15
Plan to share: No
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Nanjing Zenshine Pharmaceuticals