A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/Pharmacodynamics of iN1011-N17 after Oral Administration in Healthy Volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
This study will be conducted in approximately 104 healthy subjects in up to 13 sequential dose cohorts. Thirteen cohorts will consist of up to 8 subjects, including 2 subjects receiving placebo and 6 subjects receiving iN1011-N17. Each subsequent cohort will continue to be randomized and dosed until maximum exposure is attained or a stopping criterion has been reached.
Matching Placebo for each formulations
Nucleus Network
Melbourne, Victoria, Australia
Incidence, severity and causality of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Day 1 to Day 8
Number of participants with abnormal physical examination findings
Full physical examination will consist of the following body systems: general appearance, HEENT (head, ears, eyes, nose, and throat), cardiovascular, respiratory system, abdomen, musculoskeletal, neurological, lymph nodes, skin, and other.
Time frame: Screening, Day -1, Day 3, Day 8
Vital Signs (Blood Pressure)
Vital signs (BP) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Time frame: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
Vital Signs (Pulse)
Vital signs (Pulse) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Time frame: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
Vital Signs (Respiratory Rate)
Vital signs (RR) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Time frame: Screening, Day -1, Day 1 (pre-dose and 2, 4, 8 hours pose-dose), Day 2 (prior PK sampling), Day 3 (prior PK sampling), Day 8
Vital Signs (Body temperature)
Vital signs (Body temperature) will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
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Time frame: Screening, Day -1, Day 3 (prior PK sampling), Day 8
12-lead electrocardiogram(ECG)
ECG values will consist of QT interval, PR interval, QRS interval, RR interval and QTcF. Values will be listed and summarized at each protocol specified time point. Observed and change from baseline will be summarized at each protocol specified time point.
Time frame: Screening, Day -1, Day 1 (pre-dose and 1, 4, 8 hours pose-dose), Day 3 (prior PK sampling), Day 8
Number of participants with abnormal Laboratory tests (Hematology)
Laboratory evaluations will be listed and summarized for each scheduled visit. Observed and change from baseline clinical laboratory data will be summarized at each protocol specified time point.
Time frame: Screening, Day -1, Day 3 prior to discharge, Day 8
Number of participants with abnormal Laboratory tests (Biochemistry))
Laboratory evaluations will be listed and summarized for each scheduled visit. Observed and change from baseline clinical laboratory data will be summarized at each protocol specified time point.
Time frame: Screening, Day -1, Day 3 prior to discharge, Day 8
Maximum plasma concentration (Cmax)
Time frame: 0-48 hours post dose
Time to maximum plasma concentration (tmax)
Time frame: 0-48 hours post dose
Terminal half-life (t1/2)
Time frame: 0-48 hours post dose
Area under the plasma concentration curve (AUClast, AUCinf)
Time frame: 0-48 hours post dose
Apparent volume of distribution (Vz/F)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Apparent plasma elimination rate constant (λz)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Apparent clearance (CL/F)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Fraction excreted unchanged in urine (fe)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Amount of drug excreted unchanged in the urine (Ae)
Time frame: 0-48 hours post dose on Day 1 to Day 3
Renal clearance (CLR)
Time frame: 0-48 hours post dose on Day 1 to Day 3