The purpose of this study was to investigate Safety, tolerability and pharmacokinetics in Chinese healthy subjects.
This was a single center, Phase 1, open-label SAD and MAD study designed to assess safety, tolerability and PK of orally administered THR-1442 tablets in Chinese healthy adults. Subjects were enrolled to receive 20mg THR-1442 tablet in Single dose group (20mg\*1 day) and multiple dose group(20mg\*7days). Blood samples for THR-1442 plasma concentrations were collected 0h till to 48hours.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
THR-1442 20mg is administrated 1 dose on Day 1, then follow till day 7.
THR-1442 20mg is administrated QD for 7days, then follow till day 14.
Hangzhou First People's hospital
Hangzhou, Zhejiang, China
RECRUITINGCollect and evaluate TEAEs (including clinical AEs and Lab AEs) of THR-1442 in healthy subjects during study
Collect data(TEAEs including clinical AEs and lab AEs) on Day7 and Day14 to evaluate THR1442 safety and tolerability
Time frame: Single dose:Baseline to day 7 ; Multiple dose:Baseline to Day14
Select and evaluate pharmacokinetic characteristics(AUC) of THR-1442 in healthy subjects during the study
Collect blood samples on Single dose part and multiple dose part to evaluate THR1442 PK parameters (AUC)
Time frame: Single dose:Day1-Day7; Multiple dose:Day1- Day14
Select and evaluate pharmacokinetic characteristics(Cmax) of THR-1442 in healthy subjects during the study
Collect blood samples on Single dose part and multiple dose part to evaluate THR1442 PK parameters (Cmax)
Time frame: Single dose:Day1-Day7; Multiple dose:Day1- Day14
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