The goal of this clinical trial is to learn about ISM5411 in healthy subjects. The primary objective is to evaluate the safety and tolerability of single and multiple oral doses of ISM5411 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
79
Nucleus Network
Melbourne, Victoria, Australia
Number of participants with Adverse Events (AEs) after single or multiple doses of ISM5411.
The number of participants with treatment related AEs as assessed by CTCAE v5.0. will be monitored.
Time frame: Up to 7 days after last dose.
Number of participants with clinically significant changes in vital signs
The number of participants with clinically significant changes in vital signs will be monitored based on the assessment of blood pressure, heart rate, respiration and body temperature before and after administration.
Time frame: Up to 7 days after last dose.
Number of participants with clinically significant changes in in chemistry laboratory values
The number of participants with clinically significant changes in blood routine, blood biochemistry, urine routine, coagulation function, etc. will be monitored before and after administration.
Time frame: Up to 7 days after last dose
Number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) readings
The number of participants with clinically significant changes in 12-lead Electrocardiogram (ECG) readings will be monitored based on changes in cardiovascular system function (change in QTC parameters) as a criterion of safety and tolerability variables.
Time frame: Up to 7 days after last dose
Number of participants with clinically significant changes in physical examinations
Complete physical examination should include the head and face, skin system, lymph nodes, eyes, ears, nose and throat, mouth, respiratory system, cardiovascular system, abdomen, musculoskeletal system, nervous system and mental status.
Time frame: Up to 7 days after last dose
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Maximum plasma concentration (Cmax) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Time at which the maximum plasma concentration occurred (tmax) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Area under the plasma concentration-time curve from time zero to time with last measurable concentration t (AUC0-t) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Elimination rate constant (λz) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Elimination half-life (t1/2) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Apparent volume of distribution (Vz/F) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Apparent total plasma clearance (CL/F) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Mean residence time (MRT) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Renal clearance rate (CLR) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Accumulative excretion (Ae) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Fractional excretion (fe) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17
Relative bioavailability (fed/fasted) of ISM5411
To evaluate the pharmacokinetics (PK) characteristics of ISM5411 in healthy subjects.
Time frame: Day 1 through Day 17