This is a single-dose orally administered, dose-escalation, single-center, randomized, double-blind, placebo-parallel controlled clinical study evaluating the effect of TPN171H tablets on QT/QTc interval in healthy subjects.The main objective was to evaluate the effect of TPN171H tablets on QT/QTc interval in healthy Chinese subjects after a single oral administration.
This trial was a single-center, randomized, double-blind, placebo parallel controlled trial of TPN171H tablets with single oral administration, dose escalation, in healthy Chinese subjects. This trial plans to set up 4 dose groups, and a total of 32 healthy adult subjects are expected to be enrolled. All subjects will receive a single oral dose under fasting state, and complete 3 days of PK blood sampling, 12-lead ECG examination and other safety checks. The trial was sequential according to the principle of dose escalation, that is, the next dose group was tested on the premise that the safety and tolerability of the previous group were good.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
6 subjects will receive TPN171H 10 mg, orally; 2 subjects will receive placebo, orally.
6 subjects will receive TPN171H 30 mg, orally; 2 subjects will receive placebo, orally.
6 subjects will receive TPN171H 40 mg, orally; 2 subjects will receive placebo, orally.
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
QT Interval Corrected Using Fridericia's Formula
Model-guided placebo-corrected change in QTcF from baseline (ΔΔQTcF)
Time frame: From Day 1 to Day3
QT Interval
Change in QT interval from baseline
Time frame: From Day 1 to Day3
Corrected QT interval
Change in QTc interval from baseline
Time frame: From Day 1 to Day3
PR interval
Change in PR interval from baseline
Time frame: From Day 1 to Day3
RR interval
Change in RR interval from baseline
Time frame: From Day 1 to Day3
QRS duration
Change in QRS duration limit interval from baseline
Time frame: From Day 1 to Day3
Heart rate
Change in HR from baseline
Time frame: From Day 1 to Day3
T-wave
Whether the T-wave shape is abnormal
Time frame: From Day 1 to Day3
U-wave
Whether the U-wave shape is abnormal
Time frame: From Day 1 to Day3
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6 subjects will receive TPN171H 50 mg, orally; 2 subjects will receive placebo, orally.
Number of participants with arrhythmic
Number of participants with arrhythmic, arrhythmic includes Atrial fibrillation, atrial flutter, atrioventricular block, ST segment changes, etc
Time frame: From Day 1 to Day3
Tmax
time to peak
Time frame: From Day 1 to Day3
Cmax
maximum concentration
Time frame: From Day 1 to Day3
plasma half-life(T1/2)
Elimination half life
Time frame: From Day 1 to Day3
Area under concentration-time curve (AUC0-t)
Area under concentration-time curve (AUC0-t)
Time frame: From Day 1 to Day3
Incidence of adverse events
Incidence of adverse events
Time frame: From Day 1 to Day3
Severity of adverse events
Severity of adverse events
Time frame: From Day 1 to Day3