This single-center, randomized, double-blind, placebo-controlled, two-part study is designed to assess the safety, tolerability and PK of oral HL-1186 Tablet in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
HL-1186 tablet for oral administration.
HL-1186 placebo tablet for oral administration.
Jiangnan University Affiliated Hospital
Wuxi, China
RECRUITINGTo assess the safety and tolerability of single and multiple doses of HL-1186 in healthy participants
Number of participants with adverse events, with abnormal physical examination finding, with abnormal vital signs, abnormal 12-lead electrocardiograms and abnormal laboratory tests results (hematology, urinalysis, clinical chemistry, coagulation function
Time frame: Single ascending dose(SAD): day1 to day14; Food effect(FE): day1 to day21; Multiple ascending dose(MAD): day1 to day27
To assess the pharmacokinetic parameters of HL-1186 in healthy participants
Time to reach maximum concentration (Tmax)
Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20
To assess the pharmacokinetic parameters of HL-1186 in healthy participants
Maximum concentration (Cmax)
Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20
To assess the pharmacokinetic parameters of HL-1186 in healthy participants
Area under the plasma concentration-time curve from time 0 to last time of quantifiable concentration (AUC0-t)
Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20
To assess the pharmacokinetic parameters of HL-1186 in healthy participants
Elimination half time (T1/2)
Time frame: Single ascending dose(SAD): day1 to day7; Food effect(FE): day1 to day14; Multiple ascending dose(MAD): day1 to day20
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