The purpose of this first in human study is to evaluate the safety, tolerability, pharmacokinetics (PK),and pharmacodynamics (PD) of HS-10390 in healthy subjects.
This is a Phase 1, randomized, double-blind, placebo-controlled, single and multiple ascendingdose (SAD and MAD) study to evaluate the safety, tolerability, PK, and PD of different doses of HS-10390 tablet(s) in healthy subjects. During the SAD and MAD periods, there will be approximately 6and 3 sequential cohorts respectively. A sentinel dosing strategy will be used in the first cohort ofSAD. The MAD study will start after sufficient safety and PK data of SAD period are obtained.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Oral administration of specified dose of HS-10390
Oral administration of matching dose ofplacebo
Zhongda Hospital, Affiliated to Southeast University
Nanjing, Jiangsu, China
RECRUITINGIncidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 28 (MAD)
Maximum plasma concentration (Cmax)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Time to reach Cmax (Tmax)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Area under the plasma concentration-time curve from time zero to time t (AUC0-t)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Half time (t½)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent clearance (CL/F)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Apparent volume of distribution (Vz/F)
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Accumulation ratio(Rac)
Time frame: Day 14 up to Day 19 (MAD)
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