The purpose of this first-in-human study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of HS-10374 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
Single or multiple dosing of HS-10374 orally in a fasting state
Single or multiple dosing of HS-10374-matched placebo orally in a fasting state
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Incidence, 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 42 (MAD)
Number of participants with clinical laboratory abnormalities
Clinical laboratory tests include hematology, urinalysis, stool analysis, blood chemistry, coagulation testing, Cystatin C, urine β2-microglobulin, erythrocyte sedimentation rate, C-reactive protein, etc.
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with abnormalities of vital signs
Vital sign measured include blood pressure, pulse rate, temperature, and respiration rate.
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with abnormalities of physical examination
Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Number of participants with abnormalities of electrocardiogram (ECG) parameters
ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.
Time frame: Day 1 up to Day 12 (SAD), Day 1 up to Day 42 (MAD)
Cmax
Maximum plasma concentration
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Tmax
Time to reach Cmax
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Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
AUC
Area under the plasma concentration-time curve
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
t½
Terminal half-life
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
CL/F
Apparent clearance
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Vz/F
Apparent volume of distribution
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)
Rac
Accumulation ratio
Time frame: Day 1 up to Day 6 (SAD), Day 1 up to Day 19 (MAD)